Oxygen

Oxygen
SPL v6
SPL
SPL Set ID e1e64161-2bbf-7b23-e053-2995a90a376b
Route
RESPIRATORY (INHALATION)
Published
Effective Date 2025-12-08
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxygen (995 mL)

Identifiers & Packaging

Marketing Status
NDA Active Since 2022-06-30

Description

ABSOLUTE AIR Shipped From: Absolute Air LLC 1305 40th Street NW Faribault, MN 55021 763-551-5393 Certificate of Analysis Customer TOLL Product Oxygen, USP Time In 11/25/2025 13:10:12 Time Out 11/25/2025 13:37:49 Trailer T02 Load 7 Lot 55021-O-25-329-7-T02 Gross Weight, lbs 79500 Tare Weight, lbs 48860 Net Weight, lbs 30640 Post-Fill Result Specification Method Purity, % (v/v) 99.74 > = 99.5 Teledyne 3010MA Paramagnetic Odor None None Organoleptic This product was manufactured by air liquefaction. Therefore, carbon monoxide and carbon dioxide testing is exempt under the USP compendium. NDA 217500 Analyst: I declare that this analysis was completed within all Absolute Air policies and procedures and that the produce meets Absolute Air specifications. Signed Date/Time Released By: I declare that this certificate is accurate, complete, and compliant with all applicable policies and procedures and that the product meets Absolute Air specifications. Signed Date/Tim Warning: For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other Medical applications, Rx required. No smoking or vaping. Keep away from open flame. Produced by air liquefaction.


Medication Information

Description

ABSOLUTE AIR Shipped From: Absolute Air LLC 1305 40th Street NW Faribault, MN 55021 763-551-5393 Certificate of Analysis Customer TOLL Product Oxygen, USP Time In 11/25/2025 13:10:12 Time Out 11/25/2025 13:37:49 Trailer T02 Load 7 Lot 55021-O-25-329-7-T02 Gross Weight, lbs 79500 Tare Weight, lbs 48860 Net Weight, lbs 30640 Post-Fill Result Specification Method Purity, % (v/v) 99.74 > = 99.5 Teledyne 3010MA Paramagnetic Odor None None Organoleptic This product was manufactured by air liquefaction. Therefore, carbon monoxide and carbon dioxide testing is exempt under the USP compendium. NDA 217500 Analyst: I declare that this analysis was completed within all Absolute Air policies and procedures and that the produce meets Absolute Air specifications. Signed Date/Time Released By: I declare that this certificate is accurate, complete, and compliant with all applicable policies and procedures and that the product meets Absolute Air specifications. Signed Date/Tim Warning: For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other Medical applications, Rx required. No smoking or vaping. Keep away from open flame. Produced by air liquefaction.

Section 51945-4

ABSOLUTE AIR

Shipped From:

Absolute Air LLC

1305 40th Street NW

Faribault, MN 55021

763-551-5393

Certificate of Analysis

Customer TOLL

Product Oxygen, USP

Time In 11/25/2025 13:10:12

Time Out 11/25/2025 13:37:49

Trailer T02

Load 7

Lot 55021-O-25-329-7-T02

Gross Weight, lbs 79500

Tare Weight, lbs 48860

Net Weight, lbs 30640

Post-Fill Result Specification Method

Purity, % (v/v) 99.74 > = 99.5 Teledyne 3010MA Paramagnetic

Odor None None Organoleptic

This product was manufactured by air liquefaction. Therefore, carbon monoxide and carbon dioxide testing is exempt under the USP compendium. NDA 217500

Analyst: I declare that this analysis was completed within all Absolute Air policies and procedures and that the produce meets Absolute Air specifications.

Signed Date/Time

Released By: I declare that this certificate is accurate, complete, and compliant with all applicable policies and procedures and that the product meets Absolute Air specifications.

Signed Date/Tim

Warning: For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other Medical applications, Rx required.

No smoking or vaping. Keep away from open flame.

Produced by air liquefaction.


Structured Label Content

Section 51945-4 (51945-4)

ABSOLUTE AIR

Shipped From:

Absolute Air LLC

1305 40th Street NW

Faribault, MN 55021

763-551-5393

Certificate of Analysis

Customer TOLL

Product Oxygen, USP

Time In 11/25/2025 13:10:12

Time Out 11/25/2025 13:37:49

Trailer T02

Load 7

Lot 55021-O-25-329-7-T02

Gross Weight, lbs 79500

Tare Weight, lbs 48860

Net Weight, lbs 30640

Post-Fill Result Specification Method

Purity, % (v/v) 99.74 > = 99.5 Teledyne 3010MA Paramagnetic

Odor None None Organoleptic

This product was manufactured by air liquefaction. Therefore, carbon monoxide and carbon dioxide testing is exempt under the USP compendium. NDA 217500

Analyst: I declare that this analysis was completed within all Absolute Air policies and procedures and that the produce meets Absolute Air specifications.

Signed Date/Time

Released By: I declare that this certificate is accurate, complete, and compliant with all applicable policies and procedures and that the product meets Absolute Air specifications.

Signed Date/Tim

Warning: For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other Medical applications, Rx required.

No smoking or vaping. Keep away from open flame.

Produced by air liquefaction.


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Raw Label Data

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