Oxygen

Oxygen
SPL v11
SPL
SPL Set ID 7bc13cd0-d084-1afd-e053-2991aa0a9717
Route
RESPIRATORY (INHALATION)
Published
Effective Date 2019-03-08
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxygen (990 mL)

Identifiers & Packaging

Marketing Status
NDA Active Since 2018-11-01

Description

UIG Universal Industrial Gases, Inc Certificate of Analysis All USP Oxygen delivered by Universal Industrial Gases, Inc, when used in a medical application or by medical customers properly registered with the FDA, is classified as USP Shipped From Taylor Data Systems 181 E. Evans St Suite A Florence, SC 29505 843-656-2084 Company: Taylor Data Systems Operator: Admin Product: Oxygen Product Code: OX 200 Driver: Benton Little Tractor No: 14 Trailer No: 12 Load No: 111 Certificate No: 242 Tank No: 1000 Time In: 10:47 AM Time Out: 10:49 AM Certification Date: 6/22/2018 10:49 AM Tare Weight: 10000 lbs Gross Weight: 10000 lbs Net Weight: 0 lbs Lot Number: TDS-161-18-O-1000-2 Produced by: Tyler Results Units USP/NF Specifications TDS Specifications Purity Pre-Fill 97.00 % >=97.00 % >=97.00 % Purity Post-Fill 99.00 $ >=99.00 % >=99.50 % Paramagnetic Odor None None None Organoleptic Identity Oxygen Oxygen Oxygen Dew Point -85.50 deg. F 0.00 deg. F Moisture 5.00 ppm/V <=5.00 ppm/V - Critical Analyzers Yes Yes *The Pre-Fill is tested against UIGI specifications and a Pass indicates that the results met or exceeded the applicable specifications. The results of the Pre-Fill tests are kept on file. Quantity delivered to trailer: 0.00 Gallons: 1.26 Cubic Feet: 0.00 UIGI Analyst: I declare that this analysis was completed within all UIGI policy and procedures and that the product meets all UIGI specifications. Signed: Date: 06/22/2018 Product Release Specialist / Released By: I declare that this certificate is accurate, complete and compliant with all applicable policies and procedures, that all pre-fill inspections including inspection of the loading hose and connections were performed following all applicable procedures, and that the product meets all UIGI specifications. Signed: Date: 06/22/2018 Picked Up By: I declare that I have received the required documentation for shipment of this product and that I have the North American Emergency Response Guide or a SDS. Signed: Date: 06/22/2018


Medication Information

Description

UIG Universal Industrial Gases, Inc Certificate of Analysis All USP Oxygen delivered by Universal Industrial Gases, Inc, when used in a medical application or by medical customers properly registered with the FDA, is classified as USP Shipped From Taylor Data Systems 181 E. Evans St Suite A Florence, SC 29505 843-656-2084 Company: Taylor Data Systems Operator: Admin Product: Oxygen Product Code: OX 200 Driver: Benton Little Tractor No: 14 Trailer No: 12 Load No: 111 Certificate No: 242 Tank No: 1000 Time In: 10:47 AM Time Out: 10:49 AM Certification Date: 6/22/2018 10:49 AM Tare Weight: 10000 lbs Gross Weight: 10000 lbs Net Weight: 0 lbs Lot Number: TDS-161-18-O-1000-2 Produced by: Tyler Results Units USP/NF Specifications TDS Specifications Purity Pre-Fill 97.00 % >=97.00 % >=97.00 % Purity Post-Fill 99.00 $ >=99.00 % >=99.50 % Paramagnetic Odor None None None Organoleptic Identity Oxygen Oxygen Oxygen Dew Point -85.50 deg. F 0.00 deg. F Moisture 5.00 ppm/V <=5.00 ppm/V - Critical Analyzers Yes Yes *The Pre-Fill is tested against UIGI specifications and a Pass indicates that the results met or exceeded the applicable specifications. The results of the Pre-Fill tests are kept on file. Quantity delivered to trailer: 0.00 Gallons: 1.26 Cubic Feet: 0.00 UIGI Analyst: I declare that this analysis was completed within all UIGI policy and procedures and that the product meets all UIGI specifications. Signed: Date: 06/22/2018 Product Release Specialist / Released By: I declare that this certificate is accurate, complete and compliant with all applicable policies and procedures, that all pre-fill inspections including inspection of the loading hose and connections were performed following all applicable procedures, and that the product meets all UIGI specifications. Signed: Date: 06/22/2018 Picked Up By: I declare that I have received the required documentation for shipment of this product and that I have the North American Emergency Response Guide or a SDS. Signed: Date: 06/22/2018

Section 51945-4

UIG Universal Industrial Gases, Inc

Certificate of Analysis

All USP Oxygen delivered by Universal Industrial Gases, Inc, when used in a medical application or by medical customers properly registered with the FDA, is classified as USP

Shipped From

Taylor Data Systems

181 E. Evans St

Suite A

Florence, SC 29505

843-656-2084

Company: Taylor Data Systems Operator: Admin

Product: Oxygen Product Code: OX 200

Driver: Benton Little Tractor No: 14 Trailer No: 12

Load No: 111 Certificate No: 242 Tank No: 1000

Time In: 10:47 AM Time Out: 10:49 AM Certification Date: 6/22/2018 10:49 AM

Tare Weight: 10000 lbs Gross Weight: 10000 lbs Net Weight: 0 lbs

Lot Number: TDS-161-18-O-1000-2 Produced by: Tyler

Results Units USP/NF Specifications TDS Specifications

Purity Pre-Fill 97.00 % >=97.00 % >=97.00 %

Purity Post-Fill 99.00 $ >=99.00 % >=99.50 %

Paramagnetic

Odor None None None

Organoleptic

Identity Oxygen Oxygen Oxygen

Dew Point -85.50 deg. F 0.00 deg. F

Moisture 5.00 ppm/V <=5.00 ppm/V

-

Critical Analyzers Yes Yes

*The Pre-Fill is tested against UIGI specifications and a Pass indicates that the results met or exceeded the applicable specifications. The results of the Pre-Fill tests are kept on file.

Quantity delivered to trailer: 0.00 Gallons: 1.26 Cubic Feet: 0.00

UIGI Analyst: I declare that this analysis was completed within all UIGI policy and procedures and that the product meets all UIGI specifications.

Signed: Date: 06/22/2018

Product Release Specialist / Released By: I declare that this certificate is accurate, complete and compliant with all applicable policies and procedures, that all pre-fill inspections including inspection of the loading hose and connections were performed following all applicable procedures, and that the product meets all UIGI specifications.

Signed: Date: 06/22/2018

Picked Up By: I declare that I have received the required documentation for shipment of this product and that I have the North American Emergency Response Guide or a SDS.

Signed: Date: 06/22/2018


Structured Label Content

Section 51945-4 (51945-4)

UIG Universal Industrial Gases, Inc

Certificate of Analysis

All USP Oxygen delivered by Universal Industrial Gases, Inc, when used in a medical application or by medical customers properly registered with the FDA, is classified as USP

Shipped From

Taylor Data Systems

181 E. Evans St

Suite A

Florence, SC 29505

843-656-2084

Company: Taylor Data Systems Operator: Admin

Product: Oxygen Product Code: OX 200

Driver: Benton Little Tractor No: 14 Trailer No: 12

Load No: 111 Certificate No: 242 Tank No: 1000

Time In: 10:47 AM Time Out: 10:49 AM Certification Date: 6/22/2018 10:49 AM

Tare Weight: 10000 lbs Gross Weight: 10000 lbs Net Weight: 0 lbs

Lot Number: TDS-161-18-O-1000-2 Produced by: Tyler

Results Units USP/NF Specifications TDS Specifications

Purity Pre-Fill 97.00 % >=97.00 % >=97.00 %

Purity Post-Fill 99.00 $ >=99.00 % >=99.50 %

Paramagnetic

Odor None None None

Organoleptic

Identity Oxygen Oxygen Oxygen

Dew Point -85.50 deg. F 0.00 deg. F

Moisture 5.00 ppm/V <=5.00 ppm/V

-

Critical Analyzers Yes Yes

*The Pre-Fill is tested against UIGI specifications and a Pass indicates that the results met or exceeded the applicable specifications. The results of the Pre-Fill tests are kept on file.

Quantity delivered to trailer: 0.00 Gallons: 1.26 Cubic Feet: 0.00

UIGI Analyst: I declare that this analysis was completed within all UIGI policy and procedures and that the product meets all UIGI specifications.

Signed: Date: 06/22/2018

Product Release Specialist / Released By: I declare that this certificate is accurate, complete and compliant with all applicable policies and procedures, that all pre-fill inspections including inspection of the loading hose and connections were performed following all applicable procedures, and that the product meets all UIGI specifications.

Signed: Date: 06/22/2018

Picked Up By: I declare that I have received the required documentation for shipment of this product and that I have the North American Emergency Response Guide or a SDS.

Signed: Date: 06/22/2018


Advanced Ingredient Data


Raw Label Data

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