País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
Oxygen (UNII: S88TT14065) (Oxygen - UNII:S88TT14065)
Messer Canada Inc.
Oxygen
Oxygen 995 mL in 1 L
RESPIRATORY (INHALATION)
PRESCRIPTION DRUG
New Drug Application
OXYGEN - OXYGEN GAS MESSER CANADA INC. ---------- OXYGEN USP BULK LIQUID WARNINGS AND PRECAUTIONS SECTION SHOULD THE MATERIAL NOT BE DELIVERED TO A USP CUSTOMER, THE MATERIAL IS “NOT APPROVED FOR HUMAN DRUG USE.” PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Messer Gases for Life Certicate of Analysis - Oxygen USP Product: Oxygen USP DATE FACILITY NAME FACILITY ADDRESS LOT# BATCH # Final Analysis Results ANALYZER # TEST/UNITSUSP SPECS ANALYSIS RESULTS N/A ODOR NONE % O2 > 99.0% (MESSER SPEC >99.50%) % PPM H2O N/A PPM PPM THC N/A PPM N/A % CO ≤ .001 *** N/A % CO2 ≤ .03 *** NT= not tested *** = This product was manufactured by Air Liquefaction and testing is exempt under the USP compendium. The methodology used to perform the USP test: Paramagnetic Analyzer Manufacturer / Model# : _______________________________________________ THIS ANALYZER HAS BEEN VALIDATED BY MESSER AS ACCEPTABLE ALTERNATIVES TO THE OFFICIAL USP FOR OXYGEN ASSAY. VALIDATION STUDY DOCUMENTATION IS MAINTAINED BY MESSER AT THE CORPORATE OFFICES. ANALYST DATE QUALITY REVIEWER DATE SHOULD THE MATERIAL NOT BE DELIVERED TO A USP CUSTOMER, THE MATERIAL IS “NOT APPROVED FOR HUMAN DRUG USE.” OXYGEN oxygen gas PRODUCT INFORMATION Messer Canada Inc. PRODUCT TYPE HUMAN PRESCRIPTION DRUG ITEM CODE (SOURCE) NDC:52003-011 ROUTE OF ADMINISTRATION RESPIRATORY (INHALATION) ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH OXYGEN (UNII: S88TT14065) (Oxygen - UNII:S88TT14065) Oxygen 995 mL in 1 L PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:52003-011- 20 18144 L in 1 TANK; Type 0: Not a Combination Product 01/01/1960 MARKETING INFORMATION MARKETING CATEGORY APPLICATION NUMBER OR MONOGRAPH CITATION MARKETING START DATE MARKETING END DATE NDA NDA205817 01/01/1960 LABELER - Messer Canada Inc. (201613189) REGISTRANT - Messer Canada Inc. (201613189) ESTABLISHMENT NAME ADDRESS ID/FEI BUSINESS OPERATIONS Messer Canada Inc. 244231937 manufacture(52003-011) , api manufacture(52003-011) Revised: 10/2023 Leia o documento completo