OXYGEN- oxygen gas

Country: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

Oxygen (UNII: S88TT14065) (Oxygen - UNII:S88TT14065)

থেকে পাওয়া:

Messer Canada Inc.

INN (International Name):

Oxygen

রচনা:

Oxygen 995 mL in 1 L

প্রশাসন রুট:

RESPIRATORY (INHALATION)

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

অনুমোদন অবস্থা:

New Drug Application

পণ্য বৈশিষ্ট্য

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