Oxygen

Oxygen
SPL v31
SPL
SPL Set ID aba44023-4919-4711-992c-aa59dfe366a9
Route
RESPIRATORY (INHALATION)
Published
Effective Date 2025-10-31
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxygen (991 mL)

Identifiers & Packaging

Marketing Status
NDA Active Since 1996-06-01 Until 2022-01-25

Description

nexAir OXYGEN, COMPRESSED USP UN1072 CAS: 7782-44-7 Produced by Air Liquefaction Oxygen (O2) 100% under 2000 psi pressure (59 F or 15 C) CONTENTS: Cylinder type: Liters NDC E 680 12213-720-68 D 413 12213-720-17 Service and transfill: No user-serviceable parts. Return to distributor for service/repair. Return to Linde to be refilled. NO SMOKING NO VAPING MR CONDITIONAL Static Field Strength 3.0T Static Field Gradient 375 Gauss/cm LIV Linde Integrated Valve Portable Oxygen system. INDICATIONS FOR USE: The LIV is an integrated portable oxygen delivery system intented to provide supplemental oxygen to pediatrics and adults. The device is MR-conditional (per ASTM Standard 2503-05), and intended for use during MR imaging or MRI systems up to 3.0T. DANGER: MAY CAUSE OR INTENSIFY FIRE; OXIDIZER. CONTAINS GAS UNDER PRESURE; MAY EXPLODE IF HEATED. Do not handle until all safety precautions have been read and understood. Keep and store away from clothing and other combustible materials. Keep valves and fittings free from grease and oil. Use and store only outdoors or in a well-ventilated place. In case of fire: Stop leak if safe to do so. Use a back flow preventive device in the piping. Use only with equipment of compatible materials of construction and rated for cylinder pressure. Use only with equipment cleaned for oxygen service. Open valve slowly. Close valve after each use and when empty. Protect form sunlight when ambient temperature exceeds 52 C (125 F). Read and follow the Safety Data Sheet (SDS) before use. WARNING: Keep out of reach of children. Uninterrupted use of high concentrations of oxygen over a long duration, without monitoring its effect on oxygen content and arterial blood, may be harmful. Do not attempt to use on patients who have stopped breathing unless used in conjunction with resuscitative equipment. For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx required. Federal law requires that this container be refilled with oxygen USP only by establishments registered as a drug manufacturer in accordance with the Federal Food, Drug, and Cosmetic Act. Note: Keep valve minimum 12 inches (30 cm) away from magnet opening. Do not move the package during MRI scan, as the MR data quality may be degraded. DO NOT REMOVE THIS LABEL MR CONDITIONAL Static Field Strength 3.0T Static Field Gradient 375 Gauss/cm Instructions for use Operating temperature -4 F to 113 F (-20 C to +45 C). Only use with devices intended for the product administration. Prepare to change the cylinder when the pointer on the gauge enters the red area. To ensure the correct prescribed flow rate, always make sure that the flow selector is positioned on a numbered flow setting, not between the flow settings. 1) Pressure outlet (if provided) 5) Flow Selector 2) Shut-off valve 4) Flow outlet 3) Gauge Before use: Check gauge (3) for content. Check flow selector (5) is set at zero. Connect equipment to outlet (1 or 4). Slowly open shut off valve (2) fully by turning counterclockwise. If equipment is connected to the flow outlet (4) select flow by turning flow selector (5) stepwise up through flow settings. The patient can now be connected to a delivery device After use: Turn flow selector (5) to zero by turning the flow selector stepwise down through flow settings. Close shut off valve (2) by turning clockwise. Vent downstream equipment. Disconnect the equipment from outlet (1 or 4). Distributed by: nexAir, LLC 1350 Concourse Ave., Suite 103 Memphis, TN 38104 888-639-2475 www.nexAir.com


Medication Information

Description

nexAir OXYGEN, COMPRESSED USP UN1072 CAS: 7782-44-7 Produced by Air Liquefaction Oxygen (O2) 100% under 2000 psi pressure (59 F or 15 C) CONTENTS: Cylinder type: Liters NDC E 680 12213-720-68 D 413 12213-720-17 Service and transfill: No user-serviceable parts. Return to distributor for service/repair. Return to Linde to be refilled. NO SMOKING NO VAPING MR CONDITIONAL Static Field Strength 3.0T Static Field Gradient 375 Gauss/cm LIV Linde Integrated Valve Portable Oxygen system. INDICATIONS FOR USE: The LIV is an integrated portable oxygen delivery system intented to provide supplemental oxygen to pediatrics and adults. The device is MR-conditional (per ASTM Standard 2503-05), and intended for use during MR imaging or MRI systems up to 3.0T. DANGER: MAY CAUSE OR INTENSIFY FIRE; OXIDIZER. CONTAINS GAS UNDER PRESURE; MAY EXPLODE IF HEATED. Do not handle until all safety precautions have been read and understood. Keep and store away from clothing and other combustible materials. Keep valves and fittings free from grease and oil. Use and store only outdoors or in a well-ventilated place. In case of fire: Stop leak if safe to do so. Use a back flow preventive device in the piping. Use only with equipment of compatible materials of construction and rated for cylinder pressure. Use only with equipment cleaned for oxygen service. Open valve slowly. Close valve after each use and when empty. Protect form sunlight when ambient temperature exceeds 52 C (125 F). Read and follow the Safety Data Sheet (SDS) before use. WARNING: Keep out of reach of children. Uninterrupted use of high concentrations of oxygen over a long duration, without monitoring its effect on oxygen content and arterial blood, may be harmful. Do not attempt to use on patients who have stopped breathing unless used in conjunction with resuscitative equipment. For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx required. Federal law requires that this container be refilled with oxygen USP only by establishments registered as a drug manufacturer in accordance with the Federal Food, Drug, and Cosmetic Act. Note: Keep valve minimum 12 inches (30 cm) away from magnet opening. Do not move the package during MRI scan, as the MR data quality may be degraded. DO NOT REMOVE THIS LABEL MR CONDITIONAL Static Field Strength 3.0T Static Field Gradient 375 Gauss/cm Instructions for use Operating temperature -4 F to 113 F (-20 C to +45 C). Only use with devices intended for the product administration. Prepare to change the cylinder when the pointer on the gauge enters the red area. To ensure the correct prescribed flow rate, always make sure that the flow selector is positioned on a numbered flow setting, not between the flow settings. 1) Pressure outlet (if provided) 5) Flow Selector 2) Shut-off valve 4) Flow outlet 3) Gauge Before use: Check gauge (3) for content. Check flow selector (5) is set at zero. Connect equipment to outlet (1 or 4). Slowly open shut off valve (2) fully by turning counterclockwise. If equipment is connected to the flow outlet (4) select flow by turning flow selector (5) stepwise up through flow settings. The patient can now be connected to a delivery device After use: Turn flow selector (5) to zero by turning the flow selector stepwise down through flow settings. Close shut off valve (2) by turning clockwise. Vent downstream equipment. Disconnect the equipment from outlet (1 or 4). Distributed by: nexAir, LLC 1350 Concourse Ave., Suite 103 Memphis, TN 38104 888-639-2475 www.nexAir.com

Section 51945-4

nexAir

OXYGEN, COMPRESSED USP

UN1072

CAS: 7782-44-7

Produced by Air Liquefaction

Oxygen (O2) 100% under 2000 psi pressure (59 F or 15 C)

CONTENTS:

Cylinder type: Liters NDC

E 680 12213-720-68

D 413 12213-720-17

Service and transfill: No user-serviceable parts. Return to distributor for service/repair. Return to Linde to be refilled.

NO SMOKING NO VAPING

MR CONDITIONAL

Static Field Strength 3.0T

Static Field Gradient 375 Gauss/cm

LIV Linde Integrated Valve Portable Oxygen system.

INDICATIONS FOR USE: The LIV is an integrated portable oxygen delivery system intented to provide supplemental oxygen to pediatrics and adults. The device is MR-conditional (per ASTM Standard 2503-05), and intended for use during MR imaging or MRI systems up to 3.0T.

DANGER: MAY CAUSE OR INTENSIFY FIRE; OXIDIZER. CONTAINS GAS UNDER PRESURE; MAY EXPLODE IF HEATED.

Do not handle until all safety precautions have been read and understood. Keep and store away from clothing and other combustible materials. Keep valves and fittings free from grease and oil. Use and store only outdoors or in a well-ventilated place. In case of fire: Stop leak if safe to do so. Use a back flow preventive device in the piping. Use only with equipment of compatible materials of construction and rated for cylinder pressure. Use only with equipment cleaned for oxygen service. Open valve slowly. Close valve after each use and when empty. Protect form sunlight when ambient temperature exceeds 52 C (125 F). Read and follow the Safety Data Sheet (SDS) before use.

WARNING: Keep out of reach of children. Uninterrupted use of high concentrations of oxygen over a long duration, without monitoring its effect on oxygen content and arterial blood, may be harmful. Do not attempt to use on patients who have stopped breathing unless used in conjunction with resuscitative equipment. For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx required.

Federal law requires that this container be refilled with oxygen USP only by establishments registered as a drug manufacturer in accordance with the Federal Food, Drug, and Cosmetic Act.

Note: Keep valve minimum 12 inches (30 cm) away from magnet opening. Do not move the package during MRI scan, as the MR data quality may be degraded.

DO NOT REMOVE THIS LABEL

MR CONDITIONAL

Static Field Strength 3.0T

Static Field Gradient 375 Gauss/cm

Instructions for use

Operating temperature -4 F to 113 F (-20 C to +45 C).

Only use with devices intended for the product administration.

Prepare to change the cylinder when the pointer on the gauge enters the red area.

To ensure the correct prescribed flow rate, always make sure that the flow selector is positioned on a numbered flow setting, not between the flow settings.

1) Pressure outlet (if provided) 5) Flow Selector

2) Shut-off valve 4) Flow outlet

3) Gauge

Before use:

Check gauge (3) for content.

Check flow selector (5) is set at zero.

Connect equipment to outlet (1 or 4).

Slowly open shut off valve (2) fully by turning counterclockwise.

If equipment is connected to the flow outlet (4) select flow by turning flow selector (5) stepwise up through flow settings.

The patient can now be connected to a delivery device

After use:

Turn flow selector (5) to zero by turning the flow selector stepwise down through flow settings.

Close shut off valve (2) by turning clockwise.

Vent downstream equipment.

Disconnect the equipment from outlet (1 or 4).

Distributed by:

nexAir, LLC

1350 Concourse Ave., Suite 103

Memphis, TN 38104

888-639-2475 www.nexAir.com


Structured Label Content

Section 51945-4 (51945-4)

nexAir

OXYGEN, COMPRESSED USP

UN1072

CAS: 7782-44-7

Produced by Air Liquefaction

Oxygen (O2) 100% under 2000 psi pressure (59 F or 15 C)

CONTENTS:

Cylinder type: Liters NDC

E 680 12213-720-68

D 413 12213-720-17

Service and transfill: No user-serviceable parts. Return to distributor for service/repair. Return to Linde to be refilled.

NO SMOKING NO VAPING

MR CONDITIONAL

Static Field Strength 3.0T

Static Field Gradient 375 Gauss/cm

LIV Linde Integrated Valve Portable Oxygen system.

INDICATIONS FOR USE: The LIV is an integrated portable oxygen delivery system intented to provide supplemental oxygen to pediatrics and adults. The device is MR-conditional (per ASTM Standard 2503-05), and intended for use during MR imaging or MRI systems up to 3.0T.

DANGER: MAY CAUSE OR INTENSIFY FIRE; OXIDIZER. CONTAINS GAS UNDER PRESURE; MAY EXPLODE IF HEATED.

Do not handle until all safety precautions have been read and understood. Keep and store away from clothing and other combustible materials. Keep valves and fittings free from grease and oil. Use and store only outdoors or in a well-ventilated place. In case of fire: Stop leak if safe to do so. Use a back flow preventive device in the piping. Use only with equipment of compatible materials of construction and rated for cylinder pressure. Use only with equipment cleaned for oxygen service. Open valve slowly. Close valve after each use and when empty. Protect form sunlight when ambient temperature exceeds 52 C (125 F). Read and follow the Safety Data Sheet (SDS) before use.

WARNING: Keep out of reach of children. Uninterrupted use of high concentrations of oxygen over a long duration, without monitoring its effect on oxygen content and arterial blood, may be harmful. Do not attempt to use on patients who have stopped breathing unless used in conjunction with resuscitative equipment. For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx required.

Federal law requires that this container be refilled with oxygen USP only by establishments registered as a drug manufacturer in accordance with the Federal Food, Drug, and Cosmetic Act.

Note: Keep valve minimum 12 inches (30 cm) away from magnet opening. Do not move the package during MRI scan, as the MR data quality may be degraded.

DO NOT REMOVE THIS LABEL

MR CONDITIONAL

Static Field Strength 3.0T

Static Field Gradient 375 Gauss/cm

Instructions for use

Operating temperature -4 F to 113 F (-20 C to +45 C).

Only use with devices intended for the product administration.

Prepare to change the cylinder when the pointer on the gauge enters the red area.

To ensure the correct prescribed flow rate, always make sure that the flow selector is positioned on a numbered flow setting, not between the flow settings.

1) Pressure outlet (if provided) 5) Flow Selector

2) Shut-off valve 4) Flow outlet

3) Gauge

Before use:

Check gauge (3) for content.

Check flow selector (5) is set at zero.

Connect equipment to outlet (1 or 4).

Slowly open shut off valve (2) fully by turning counterclockwise.

If equipment is connected to the flow outlet (4) select flow by turning flow selector (5) stepwise up through flow settings.

The patient can now be connected to a delivery device

After use:

Turn flow selector (5) to zero by turning the flow selector stepwise down through flow settings.

Close shut off valve (2) by turning clockwise.

Vent downstream equipment.

Disconnect the equipment from outlet (1 or 4).

Distributed by:

nexAir, LLC

1350 Concourse Ave., Suite 103

Memphis, TN 38104

888-639-2475 www.nexAir.com


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