Oxygen
FDA Label NDC 55586-001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sims Welding Supply Co, Inc. for the product Oxygen (NDC 55586-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding oxygen certificate of analysis, warnings and precautions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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:___________________

Oxygen Coa (Sims Ws Coa O2)

Oxygen Coa (Sims Ws Coa O2)

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.

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