Oxygen - 001

Oxygen - 001
SPL v11
SPL
SPL Set ID 66767af9-a49d-4441-b7ad-a2632aa5604c
Route
RESPIRATORY (INHALATION)
Published
Effective Date 2024-10-10
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxygen (99 L)

Identifiers & Packaging

Marketing Status
NDA Active Since 2007-12-15
Description

THIS DOCUMENT IS THE CERTIFICATE OF ANALYSIS OF OXYGEN USP LOT # ______________________ SUPPLIED TO YOU IN A TRAILER FROM OUR BILLINGS MONTANA LOCATION OR PICKED UP BY THE CUSTOMER LISTED ABOVE IN THEIR TRAILER.  FOLLOWING THE ASPEN AIR MEDICAL GAS PROCEDURES OUR LOCATION ENSURES THAT THE OXYGEN USP PRODUCT IS MANUFACTURED IN COMPLIANCE WITH THE FDA'S CURRENT GOOD MANUFACTURING PRACTICE REGULATIONS AND THE FDA'S MEDICAL GAS GUIDELINES.  THIS DOCUMENT IS INTENDED TO SERVE AS A CERTIFICATE OF ANALYSIS FOR THE OXYGEN USP WHEN THE RESULTS OF THE PRODUCT TESTING ARE ENTERED BELOW AND THE PRODUCT HAS BEEN DELIVERED TO A REGISTERED OXYGEN USP CUSTOMER.  THIS DOCUMENT IS IN COMPLIANCE WITH CURRENT FDA GUIDANCE TEST                  SPECIFICATIONS                 RESULTS ASSAY                GREATER THAN 99.5% IDENTIFICATION   OXYGEN ODOR                  NONE CARBON DIOXIDE      LESS THAN 0.03% CARBON MONOXIDE   LESS THAN 0.001% THE METHODOLOGY USED FOR PERFORMING THE USP TEST FOR ASSAY AND IDENTIFICATION IS THE PARAMAGNETIC ANALYZER MODEL # TELEDYNE 2010 MA.  THIS ANALYZER HAS BEEN VALIDATED AS AN ACCEPTABLE ALTERNATIVE TO THE OFFICIAL USP METHOD FOR OXYGEN ASSAY AND IDENTIFICATION.  THE VALIDATION STUDY IS AVAILABLE FOR REVIEW UPON REQUEST.  ODOR TESTING WAS PERFORMED BY THE OLFACTORY METHOD.  SUPPLIER SIGNATURE _________________________ DATE _________________ NUMBER 33 110 A1 - REVISION DATE 05/01/08 FOR ALL OXYGEN USP INSTALLATIONS THE DRIVER SHALL ENSURE AND DOCUMENT THE FOLLOWING: HOSECAPS (PLUGS) IN PLACE PRIOR TO DELIVERY YES/NO, GASKETS ARE SUITABLE FOR USE OR NEW YES/NO, HOSE PURGED PRIOR TO FILLING THE VESSEL YES/NO, HOSE RECAPED (PLUGGED) FOR STORAGE YES/NO. DRIVER SIGNATURE:____________________ DATE:_________________

Medication Information

Description

THIS DOCUMENT IS THE CERTIFICATE OF ANALYSIS OF OXYGEN USP LOT # ______________________ SUPPLIED TO YOU IN A TRAILER FROM OUR BILLINGS MONTANA LOCATION OR PICKED UP BY THE CUSTOMER LISTED ABOVE IN THEIR TRAILER.  FOLLOWING THE ASPEN AIR MEDICAL GAS PROCEDURES OUR LOCATION ENSURES THAT THE OXYGEN USP PRODUCT IS MANUFACTURED IN COMPLIANCE WITH THE FDA'S CURRENT GOOD MANUFACTURING PRACTICE REGULATIONS AND THE FDA'S MEDICAL GAS GUIDELINES.  THIS DOCUMENT IS INTENDED TO SERVE AS A CERTIFICATE OF ANALYSIS FOR THE OXYGEN USP WHEN THE RESULTS OF THE PRODUCT TESTING ARE ENTERED BELOW AND THE PRODUCT HAS BEEN DELIVERED TO A REGISTERED OXYGEN USP CUSTOMER.  THIS DOCUMENT IS IN COMPLIANCE WITH CURRENT FDA GUIDANCE TEST                  SPECIFICATIONS                 RESULTS ASSAY                GREATER THAN 99.5% IDENTIFICATION   OXYGEN ODOR                  NONE CARBON DIOXIDE      LESS THAN 0.03% CARBON MONOXIDE   LESS THAN 0.001% THE METHODOLOGY USED FOR PERFORMING THE USP TEST FOR ASSAY AND IDENTIFICATION IS THE PARAMAGNETIC ANALYZER MODEL # TELEDYNE 2010 MA.  THIS ANALYZER HAS BEEN VALIDATED AS AN ACCEPTABLE ALTERNATIVE TO THE OFFICIAL USP METHOD FOR OXYGEN ASSAY AND IDENTIFICATION.  THE VALIDATION STUDY IS AVAILABLE FOR REVIEW UPON REQUEST.  ODOR TESTING WAS PERFORMED BY THE OLFACTORY METHOD.  SUPPLIER SIGNATURE _________________________ DATE _________________ NUMBER 33 110 A1 - REVISION DATE 05/01/08 FOR ALL OXYGEN USP INSTALLATIONS THE DRIVER SHALL ENSURE AND DOCUMENT THE FOLLOWING: HOSECAPS (PLUGS) IN PLACE PRIOR TO DELIVERY YES/NO, GASKETS ARE SUITABLE FOR USE OR NEW YES/NO, HOSE PURGED PRIOR TO FILLING THE VESSEL YES/NO, HOSE RECAPED (PLUGGED) FOR STORAGE YES/NO. DRIVER SIGNATURE:____________________ DATE:_________________

Oxygen Certificate of Analysis

THIS DOCUMENT IS THE CERTIFICATE OF ANALYSIS OF OXYGEN USP LOT # ______________________ SUPPLIED TO YOU IN A TRAILER FROM OUR BILLINGS MONTANA LOCATION OR PICKED UP BY THE CUSTOMER LISTED ABOVE IN THEIR TRAILER.  FOLLOWING THE ASPEN AIR MEDICAL GAS PROCEDURES OUR LOCATION ENSURES THAT THE OXYGEN USP PRODUCT IS MANUFACTURED IN COMPLIANCE WITH THE FDA'S CURRENT GOOD MANUFACTURING PRACTICE REGULATIONS AND THE FDA'S MEDICAL GAS GUIDELINES.  THIS DOCUMENT IS INTENDED TO SERVE AS A CERTIFICATE OF ANALYSIS FOR THE OXYGEN USP WHEN THE RESULTS OF THE PRODUCT TESTING ARE ENTERED BELOW AND THE PRODUCT HAS BEEN DELIVERED TO A REGISTERED OXYGEN USP CUSTOMER.  THIS DOCUMENT IS IN COMPLIANCE WITH CURRENT FDA GUIDANCE

TEST                  SPECIFICATIONS                 RESULTS

ASSAY                GREATER THAN 99.5%

IDENTIFICATION   OXYGEN

ODOR                  NONE

CARBON DIOXIDE      LESS THAN 0.03%

CARBON MONOXIDE   LESS THAN 0.001%

THE METHODOLOGY USED FOR PERFORMING THE USP TEST FOR ASSAY AND IDENTIFICATION IS THE PARAMAGNETIC ANALYZER MODEL # TELEDYNE 2010 MA.  THIS ANALYZER HAS BEEN VALIDATED AS AN ACCEPTABLE ALTERNATIVE TO THE OFFICIAL USP METHOD FOR OXYGEN ASSAY AND IDENTIFICATION.  THE VALIDATION STUDY IS AVAILABLE FOR REVIEW UPON REQUEST.  ODOR TESTING WAS PERFORMED BY THE OLFACTORY METHOD.  SUPPLIER SIGNATURE _________________________ DATE _________________

NUMBER 33 110 A1 - REVISION DATE 05/01/08

FOR ALL OXYGEN USP INSTALLATIONS THE DRIVER SHALL ENSURE AND DOCUMENT THE FOLLOWING: HOSECAPS (PLUGS) IN PLACE PRIOR TO DELIVERY YES/NO, GASKETS ARE SUITABLE FOR USE OR NEW YES/NO, HOSE PURGED PRIOR TO FILLING THE VESSEL YES/NO, HOSE RECAPED (PLUGGED) FOR STORAGE YES/NO. DRIVER SIGNATURE:____________________ DATE:_________________

Structured Label Content

Oxygen Certificate of Analysis (OXYGEN CERTIFICATE OF ANALYSIS)

THIS DOCUMENT IS THE CERTIFICATE OF ANALYSIS OF OXYGEN USP LOT # ______________________ SUPPLIED TO YOU IN A TRAILER FROM OUR BILLINGS MONTANA LOCATION OR PICKED UP BY THE CUSTOMER LISTED ABOVE IN THEIR TRAILER.  FOLLOWING THE ASPEN AIR MEDICAL GAS PROCEDURES OUR LOCATION ENSURES THAT THE OXYGEN USP PRODUCT IS MANUFACTURED IN COMPLIANCE WITH THE FDA'S CURRENT GOOD MANUFACTURING PRACTICE REGULATIONS AND THE FDA'S MEDICAL GAS GUIDELINES.  THIS DOCUMENT IS INTENDED TO SERVE AS A CERTIFICATE OF ANALYSIS FOR THE OXYGEN USP WHEN THE RESULTS OF THE PRODUCT TESTING ARE ENTERED BELOW AND THE PRODUCT HAS BEEN DELIVERED TO A REGISTERED OXYGEN USP CUSTOMER.  THIS DOCUMENT IS IN COMPLIANCE WITH CURRENT FDA GUIDANCE

TEST                  SPECIFICATIONS                 RESULTS

ASSAY                GREATER THAN 99.5%

IDENTIFICATION   OXYGEN

ODOR                  NONE

CARBON DIOXIDE      LESS THAN 0.03%

CARBON MONOXIDE   LESS THAN 0.001%

THE METHODOLOGY USED FOR PERFORMING THE USP TEST FOR ASSAY AND IDENTIFICATION IS THE PARAMAGNETIC ANALYZER MODEL # TELEDYNE 2010 MA.  THIS ANALYZER HAS BEEN VALIDATED AS AN ACCEPTABLE ALTERNATIVE TO THE OFFICIAL USP METHOD FOR OXYGEN ASSAY AND IDENTIFICATION.  THE VALIDATION STUDY IS AVAILABLE FOR REVIEW UPON REQUEST.  ODOR TESTING WAS PERFORMED BY THE OLFACTORY METHOD.  SUPPLIER SIGNATURE _________________________ DATE _________________

NUMBER 33 110 A1 - REVISION DATE 05/01/08

FOR ALL OXYGEN USP INSTALLATIONS THE DRIVER SHALL ENSURE AND DOCUMENT THE FOLLOWING: HOSECAPS (PLUGS) IN PLACE PRIOR TO DELIVERY YES/NO, GASKETS ARE SUITABLE FOR USE OR NEW YES/NO, HOSE PURGED PRIOR TO FILLING THE VESSEL YES/NO, HOSE RECAPED (PLUGGED) FOR STORAGE YES/NO. DRIVER SIGNATURE:____________________ DATE:_________________

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:43:13.687669 · Updated: 2026-03-14T22:14:01.689978