OXYGEN gas

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065)

Διαθέσιμο από:

Sims Welding Supply Co, Inc.

INN (Διεθνής Όνομα):

OXYGEN

Σύνθεση:

OXYGEN 99 L in 100 L

Οδός χορήγησης:

RESPIRATORY (INHALATION)

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Καθεστώς αδειοδότησης:

unapproved medical gas

Αρχείο Π.Χ.Π.

OXYGEN - OXYGEN GAS
SIMS WELDING SUPPLY CO, INC.
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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OXYGEN CERTIFICATE OF ANALYSIS
SIMS WELDING SUPPLY QUALITY ASSURANCE PROGRAM VERSION 8 AUGUST 2007
PAGE
128
8.11 CERTIFICATE OF ANALYSIS - OXYGEN USP
CERTIFICATE OF ANALYSIS OXYGEN LIQUEFIED
CUSTOMER____ DATE______LOT#____________INVOICE#___________________
USP MEDICAL GRADE
TEST/REQUIREMENT NF SPECIFICATION LOT ANALYSIS ANALYTICAL METHOD
IDENTIFICATION PASS PARAMAGNETISM -
SERVOMEX
ODOR NO APPRECIABLE ODOR ORGANOLEPTIC
CARBON DIOXIDE LESS THAN OR EQUAL TO 0.03% SEE NOTE SEE NOTE
CARBON MONOXIDE LESS THAN OR EQUAL TO 0.001% SEE NOTE SEE NOTE
ASSAY GREATER THAN OR EQUAL TO 99.6% PARAMAGNETISM -
SERVOMEX
NOTE: USP/NF EXEMPTS FACILITIES THAT MANUFACTURE OXYGEN USP BY THE AIR
LIQUEFACTION PROCESS FROM THE TESTS FOR CARBON DIOXIDE AND CARBON
MONOXIDE. OUR OXYGEN USP IS MANUFACTURED BY THE AIR LIQUEFACTION
PROCESS
THE METHODOLOGY BEING USED TO PERFORM THE USP/NF TEST FOR ASSAY IS
INDICATED BELOW:
PARAMAGNETIC ANALYZER MODEL: SERVOMEX 5200
SUPPLIER SIGNATURE:_____________________________
DATE:___________________
WARNINGS AND PRECAUTIONS
THIS MATERIAL WAS FILLED IN ACCORDANCE WITH OUR STANDARD OPERATING
PROCEDURES UTILIZED FOR THE MANUFACTURE OF MEDICAL GASES. THESE
PROCEDURES ENSURE THAT PRODUCTS ARE SAFELY MANUFACTURED IN COMPLIANCE
WITH THE FDA'S CURRENT GOOD MANUFACTURING PRACTICES (cGMP) REGULATIONS
AND FDA MEDICAL GAS GUIDELINES FOR MEDICAL GAS CUSTOMERS. FOR NON-
MEDICAL CUSTOMERS, THIS MATERIAL IS NOT APPROVED FOR HUMAN DRUG USE.
OXYGEN
oxygen gas
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN PRESCRIPTION DRUG
ITE M CODE (SOURCE )
NDC:5558 6 -0 0 1
ROUTE OF ADMINISTRATION
RESPIRATORY (INHALATION)
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
O XYGEN (UNII: S8 8 TT140 6 5) (OXYGEN - UNII:S8 8 TT140 6 5)
OXYGEN
9 9 L in 10 0 L
Sims Welding Supply Co