NITROGEN- nitrogen gas 
Roberts Oxygen Company, Inc.

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NITROGEN REFRIGERATED LIQUID, NF -044

ROBERTS OXYGEN
ROCKVILLE, MARYLAND 20866
TEL: (301) 948-8100

CERTIFICATE OF ANALYSIS
NITROGEN REFRIGERATED LIQUID, NF*

PRODUCED BY AIR-LIQUEFACTION PROCESS

TRAILER#: ______________

DATE:  _________________

LOT#: _________________

*NF applies only when used in a medical application or by medical customers properly registered with the FDA.

Component Test Method Limit Result

NITROGEN DIFF >99.999% _______

OXYGEN ________ <3.0 PPM _______

Odor ORGANOLEPTIC N/D ______

________ _________ _________ _________

Product is identified as NITROGEN, NF 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



image description

NITROGEN 
nitrogen gas
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:46123-044
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NITROGEN (UNII: N762921K75) (NITROGEN - UNII:N762921K75) NITROGEN990 mL  in 1 L
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46123-044-011 L in 1 TANK; Type 0: Not a Combination Product07/01/2002
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20585007/01/2002
Labeler - Roberts Oxygen Company, Inc. (042646877)
Establishment
NameAddressID/FEIBusiness Operations
Roberts Oxygen Company, Inc.791818008manufacture(46123-044)

Revised: 11/2020
Document Id: b47bea77-0a19-73d2-e053-2a95a90aea66
Set id: 10211ad0-4cbd-417f-aae7-e16e4616576b
Version: 3
Effective Time: 20201119
 
Roberts Oxygen Company, Inc.