![OXYGEN GAS [ROBERTS OXYGEN COMPANY, INC.]](https://medic.hrt.org//dailymed/images/c2b0f2bd-2ce2-4096-8aae-07d2200a015b/LOX.jpg)
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PRINCIPAL DISPLAY PANEL
ROBERTS OXYGEN
ROCKVILLE, MARYLAND 20866
TEL: (301) 948-8100CERTIFICATE OF ANALYSIS
OXYGEN REFRIGERATED LIQUID, USP*PRODUCED BY AIR-LIQUEFACTION PROCESS
TRAILER#: ______________
DATE: _________________
LOT#: _________________
*USP applies only when used in a medical application or by medical customers properly registered with the FDA.
Component Test Method Limit Result
Oxygen ______ >99.5% _______
Odor ORGANOLEPTIC N/D ______
________ _________ _________ _________
Product is identified as OXYGEN, USP through process validations, dedicated piping, and product specific connections.
Notes: _____________________________________
RELEASED BY: ____________________________
SIGNATURE
RELEASED BY: ____________________________
PRINTED NAME
Printed & Published by J.J. KELLER & ASSPCIATES, INC., Neenah, WI * USP(800) 327-6868 *jjkeller.com * Printer in the Unitied States
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INGREDIENTS AND APPEARANCE
OXYGEN
oxygen gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46123-045 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN 990 mL in 1 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46123-045-01 1 L in 1 TANK; Type 0: Not a Combination Product 01/01/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA205849 01/01/2014 Labeler - Roberts Oxygen Company, Inc. (042646877) Establishment Name Address ID/FEI Business Operations Roberts Oxygen Company, Inc. 791818008 manufacture(46123-045)