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| Product NDC Code | 42914-001 | ||||
|---|---|---|---|---|---|
| Drug Name | Oxygen |
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| Type | Generic | ||||
| Active Ingredients |
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| Route | RESPIRATORY (INHALATION) | ||||
| Dosage Form | GAS | ||||
| RxCUI drug identifier | 312172 | ||||
| Application Number | NDA205862 | ||||
| Labeler Name | Aspen Air U.S., LLC | ||||
| Packages |
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Spl product data elements
Usually a list of ingredients in a drug product.OXYGEN OXYGEN OXYGEN OXYGEN
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.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:_________________ Oxygen COA
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API