Nitrogen

Nitrogen
SPL v11
SPL
SPL Set ID 7b077025-c8f6-2790-e053-2991aa0aa9c2
Route
RESPIRATORY (INHALATION)
Published
Effective Date 2018-11-19
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Nitrogen (995 mL)

Identifiers & Packaging

Marketing Status
NDA Active Since 2018-11-01
Description

UIG Universal Industrial Gases, Inc Certificate of Analysis All NF Nitrogen delivered by Universal Industrial Gases, Inc, when used in a medical application or by medical customers properly registered with the FDA, is classified as NF Nitrogen Shipped From Taylor Data Systems 181 E. Evans St Suite A Florence, SC 29505 843-656-2084 Company: Taylor Data Systems Operator: Admin Product: Nitrogen Product Code: NI 300 Driver: Test Driver Tractor No: 14 Trailer No: 123 Load No: 92 Certificate No: 214 Tank No: 1100 Time In: 12:29 PM Time Out: 2:48 PM Certification Date: 6/4/2018 2:48 PM Tare Weight: 10010 lbs Gross Weight: 45000 lbs Net Weight: 34990 lbs Lot Number: TDS-155-18-N-1100-1 Produced By: TDS Assay per NF requirements is by difference of O2 only Results Units USP/NF Specifications TDS Specifications Purity Pre-fill 99.9985 % >=99.9985 % >=99.9985 % Purity Post fill 99.9992 % >=99.00 % >=99.999 % Assay, by Difference O2 4.00 ppm/V <=1.0 % <=5.00 ppm/V O2-Nitrogen CO 4.00 ppm/V <=10.0 % <=10.00 ppm/V CO-Nitrogen Odor None None None Organoleptic Identity Nitrogen Nitrogen Nitrogen Dew Point -88.50 deg. F 0.00 deg. F Moisture 4.00 ppm/V <=5.00 ppm/V - Critical Analyzers Yes *The Pre-Fill is tested against UIGI specifications and a Pass indicates that the results met or exceeded the applicable specifications. The results of the Pre-Fill tests are kept on file. Quantity delivered to trailer: 34,990.00 Gallons: 2.04 Cubic Feet: 482966.97 UIGI Analyst: I declare that this analysis was completed within all UIGI policy and procedures and that the product meets all UIGI specifications. Signed: Date: 06/04/2018 Product Release Specialist / Released By: I declare that this certificate is accurate, complete and compliant with all applicable policies and procedures, that all pre-fill inspections including inspection of the loading hose and connections were performed following all applicable procedures, and that the product meets all UIGI specifications. Signed: Date: 06/04/2018 Picked Up By: I declare that I have received the required documentation for shipment of this product and that I have the North American Emergency Response Guide or a SDS. Signed: Date: 06/04/2018

Medication Information

Description

UIG Universal Industrial Gases, Inc Certificate of Analysis All NF Nitrogen delivered by Universal Industrial Gases, Inc, when used in a medical application or by medical customers properly registered with the FDA, is classified as NF Nitrogen Shipped From Taylor Data Systems 181 E. Evans St Suite A Florence, SC 29505 843-656-2084 Company: Taylor Data Systems Operator: Admin Product: Nitrogen Product Code: NI 300 Driver: Test Driver Tractor No: 14 Trailer No: 123 Load No: 92 Certificate No: 214 Tank No: 1100 Time In: 12:29 PM Time Out: 2:48 PM Certification Date: 6/4/2018 2:48 PM Tare Weight: 10010 lbs Gross Weight: 45000 lbs Net Weight: 34990 lbs Lot Number: TDS-155-18-N-1100-1 Produced By: TDS Assay per NF requirements is by difference of O2 only Results Units USP/NF Specifications TDS Specifications Purity Pre-fill 99.9985 % >=99.9985 % >=99.9985 % Purity Post fill 99.9992 % >=99.00 % >=99.999 % Assay, by Difference O2 4.00 ppm/V <=1.0 % <=5.00 ppm/V O2-Nitrogen CO 4.00 ppm/V <=10.0 % <=10.00 ppm/V CO-Nitrogen Odor None None None Organoleptic Identity Nitrogen Nitrogen Nitrogen Dew Point -88.50 deg. F 0.00 deg. F Moisture 4.00 ppm/V <=5.00 ppm/V - Critical Analyzers Yes *The Pre-Fill is tested against UIGI specifications and a Pass indicates that the results met or exceeded the applicable specifications. The results of the Pre-Fill tests are kept on file. Quantity delivered to trailer: 34,990.00 Gallons: 2.04 Cubic Feet: 482966.97 UIGI Analyst: I declare that this analysis was completed within all UIGI policy and procedures and that the product meets all UIGI specifications. Signed: Date: 06/04/2018 Product Release Specialist / Released By: I declare that this certificate is accurate, complete and compliant with all applicable policies and procedures, that all pre-fill inspections including inspection of the loading hose and connections were performed following all applicable procedures, and that the product meets all UIGI specifications. Signed: Date: 06/04/2018 Picked Up By: I declare that I have received the required documentation for shipment of this product and that I have the North American Emergency Response Guide or a SDS. Signed: Date: 06/04/2018

Section 51945-4

UIG Universal Industrial Gases, Inc

Certificate of Analysis

All NF Nitrogen delivered by Universal Industrial Gases, Inc, when used in a medical application or by medical customers properly registered with the FDA, is classified as NF Nitrogen

Shipped From

Taylor Data Systems

181 E. Evans St

Suite A

Florence, SC 29505

843-656-2084

Company: Taylor Data Systems Operator: Admin

Product: Nitrogen Product Code: NI 300

Driver: Test Driver Tractor No: 14 Trailer No: 123

Load No: 92 Certificate No: 214 Tank No: 1100

Time In: 12:29 PM Time Out: 2:48 PM Certification Date: 6/4/2018 2:48 PM

Tare Weight: 10010 lbs Gross Weight: 45000 lbs Net Weight: 34990 lbs

Lot Number: TDS-155-18-N-1100-1 Produced By: TDS

Assay per NF requirements is by difference of O2 only

Results Units USP/NF Specifications TDS Specifications

Purity Pre-fill 99.9985 % >=99.9985 % >=99.9985 %

Purity Post fill 99.9992 % >=99.00 % >=99.999 %

Assay, by Difference

O2 4.00 ppm/V <=1.0 % <=5.00 ppm/V

O2-Nitrogen

CO 4.00 ppm/V <=10.0 % <=10.00 ppm/V

CO-Nitrogen

Odor None None None

Organoleptic

Identity Nitrogen Nitrogen Nitrogen

Dew Point -88.50 deg. F 0.00 deg. F

Moisture 4.00 ppm/V <=5.00 ppm/V

-

Critical Analyzers Yes

*The Pre-Fill is tested against UIGI specifications and a Pass indicates that the results met or exceeded the applicable specifications. The results of the Pre-Fill tests are kept on file.

Quantity delivered to trailer: 34,990.00 Gallons: 2.04 Cubic Feet: 482966.97

UIGI Analyst: I declare that this analysis was completed within all UIGI policy and procedures and that the product meets all UIGI specifications.

Signed: Date: 06/04/2018

Product Release Specialist / Released By: I declare that this certificate is accurate, complete and compliant with all applicable policies and procedures, that all pre-fill inspections including inspection of the loading hose and connections were performed following all applicable procedures, and that the product meets all UIGI specifications.

Signed: Date: 06/04/2018

Picked Up By: I declare that I have received the required documentation for shipment of this product and that I have the North American Emergency Response Guide or a SDS.

Signed: Date: 06/04/2018

Structured Label Content

Section 51945-4 (51945-4)

UIG Universal Industrial Gases, Inc

Certificate of Analysis

All NF Nitrogen delivered by Universal Industrial Gases, Inc, when used in a medical application or by medical customers properly registered with the FDA, is classified as NF Nitrogen

Shipped From

Taylor Data Systems

181 E. Evans St

Suite A

Florence, SC 29505

843-656-2084

Company: Taylor Data Systems Operator: Admin

Product: Nitrogen Product Code: NI 300

Driver: Test Driver Tractor No: 14 Trailer No: 123

Load No: 92 Certificate No: 214 Tank No: 1100

Time In: 12:29 PM Time Out: 2:48 PM Certification Date: 6/4/2018 2:48 PM

Tare Weight: 10010 lbs Gross Weight: 45000 lbs Net Weight: 34990 lbs

Lot Number: TDS-155-18-N-1100-1 Produced By: TDS

Assay per NF requirements is by difference of O2 only

Results Units USP/NF Specifications TDS Specifications

Purity Pre-fill 99.9985 % >=99.9985 % >=99.9985 %

Purity Post fill 99.9992 % >=99.00 % >=99.999 %

Assay, by Difference

O2 4.00 ppm/V <=1.0 % <=5.00 ppm/V

O2-Nitrogen

CO 4.00 ppm/V <=10.0 % <=10.00 ppm/V

CO-Nitrogen

Odor None None None

Organoleptic

Identity Nitrogen Nitrogen Nitrogen

Dew Point -88.50 deg. F 0.00 deg. F

Moisture 4.00 ppm/V <=5.00 ppm/V

-

Critical Analyzers Yes

*The Pre-Fill is tested against UIGI specifications and a Pass indicates that the results met or exceeded the applicable specifications. The results of the Pre-Fill tests are kept on file.

Quantity delivered to trailer: 34,990.00 Gallons: 2.04 Cubic Feet: 482966.97

UIGI Analyst: I declare that this analysis was completed within all UIGI policy and procedures and that the product meets all UIGI specifications.

Signed: Date: 06/04/2018

Product Release Specialist / Released By: I declare that this certificate is accurate, complete and compliant with all applicable policies and procedures, that all pre-fill inspections including inspection of the loading hose and connections were performed following all applicable procedures, and that the product meets all UIGI specifications.

Signed: Date: 06/04/2018

Picked Up By: I declare that I have received the required documentation for shipment of this product and that I have the North American Emergency Response Guide or a SDS.

Signed: Date: 06/04/2018

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:51:05.202742 · Updated: 2026-03-14T22:39:21.707817