OXYGEN- oxygen gas

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Messer LLC

INN (International ime):

Oxygen

Sastav:

Oxygen 995 mL in 1 L

Administracija rute:

RESPIRATORY (INHALATION)

Tip recepta:

PRESCRIPTION DRUG

Status autorizacije:

New Drug Application

Svojstava lijeka

OXYGEN - OXYGEN GAS
MESSER LLC
----------
OXYGEN USP BULK LIQUID
WARNINGS 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
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:52438-011
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:52438-011-
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
NDA205767
01/01/1960
LABELER -
Messer LLC (001368141)
REGISTRANT -
Messer LLC (001368141)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
Messer LLC
943812438
manufacture(52438-011) , api manufacture(52438-011)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
Messer LLC
026946218
manufactu