Label: OXYGEN gas
- NDC Code(s): 71408-001-01
- Packager: Ineos Pigments ASU LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated October 25, 2023
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Oxygen COA
Certificate of Analysis Shipped From:
Ashtabula Oxygen
2501 Middle Rd.
Ashtabula, Ohio
Phone: (440) 994-1994
Company Name: TEST
Product: Oxygen
Load No: 6 Trailer No: 0000
Time In: 16:56:01 Time Out: 16:56:38 Load Date: 12/26/2017
Tare Weight: 0 Gross Weight: 0 lbs Net Weight: 0 lbs
Lot Number: 4004O17360060000 Produced by: Air Liquefaction
Ashtabula Oxygen
ResultsUnitsSpecifications
Purity Pre-Fill: PASS Pass*
Purity Post-Fill: 99.99 % >=99.6%
Assay, Tested By: Teledyne 3010MA Paramagnetic
- The Pre-Fill is tested against Ashtabula Oxygen and USP/NF specification and a “Pass” indicated that the results met and exceeded the applicable specifications. The results of the Pre-Fill tests are kept on file.
Ashtabula Oxygen Analyst: I declare that this analysis was completed with all Ashtabula Oxygen policy and procedures and that the product meets all Ashtabula Oxygen and USP/NF specifications.
Signed: Date/Time:
Product Release Specialist/Release By: I declare that this certification is accurate, complete and compliant with all applicable policies and procedures and that the product meets all Ashtabula Oxygen and USP/NF specifications.
Signed: Date/Time:
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 MSDS.
Signed: Date/Time:
TF-0001-O Rev.1
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INGREDIENTS AND APPEARANCE
OXYGEN
oxygen gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71408-001 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN 99 L in 100 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71408-001-01 10000 L in 1 TANK; Type 0: Not a Combination Product 12/27/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA211739 12/27/2017 Labeler - Ineos Pigments ASU LLC (080634966) Registrant - Ineos Pigments ASU LLC (080634966) Establishment Name Address ID/FEI Business Operations Ineos Pigments ASU LLC 080634966 manufacture(71408-001)