Nitrogen Refrigerated Liquid, Nf -440

SPL v2

SPL

SPL Set ID 2bed6bd8-086e-ee30-e063-6394a90ad420

Route

RESPIRATORY (INHALATION)

Published

Effective Date 2016-12-13

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Nitrogen (990 mL)

Identifiers & Packaging

Marketing Status

NDA Active Since 2002-07-01

Description

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

Medication Information

Description

Section 51945-4

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

Structured Label Content

Section 51945-4 (51945-4)

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

Advanced Ingredient Data

[{"name": "NITROGEN", "unii": "N762921K75", "classCode": "ACTIB", "strengthNumerator": "990", "strengthDenominator": "1", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "L"}]

Raw Label Data

All Sections (JSON)

{"51945-4": "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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:50:19.001348 · Updated: 2026-03-14T22:37:02.064259