Nitrogen Nf Bulk Liquid

Nitrogen Nf Bulk Liquid
SPL v21
SPL
SPL Set ID f49fbee2-8a80-477a-969b-f891ee601dc3
Route
RESPIRATORY (INHALATION)
Published
Effective Date 2025-01-16
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Nitrogen (99 L)

Identifiers & Packaging

Marketing Status
NDA Active Since 1960-01-01

Description

AIR LIQUIDE  NITROGEN N.F.        Form Number: 2A-ALL-QUA-0003-F                                                             Revision:         0                                                             Effective Date: 03/02/06                                                             Page:               1/1 CERTIFICATE OF ANALYSIS Air Liquide large Industries U.S. L.P. – Houston, TX 77056 PRODUCED BY AIR LIQUEFACTION 1.Location       Street Address1                                  2. Carrier ________________ Street Address 2 City, State Zip 3. Lot Number ______________________                4. Trailer No _____________ PRE-FILL REPORT                                                   FILL REPORT 5.Residual Assay        6. Odor                                    7. Trailer loaded with appropriate product per appropriate    (≤10 ppm O 2 )                Detected                                 loading procedure by:    _______ ppm              Yes    No                              Signature _________________________    ________                    ________                             Date _____________________________     Initial                            Initial ANALYSIS REPORT Test required               Method of Analysis                             Specifications                         Results ASSAY AND               8.PARAMAGNETIC       ___               99.998% N 2 Minimum*           10. ____% IDENTIFICATION         MICROFUEL CELL    ___                                   ELECTROCHEMICAL ___                                                CELL                                           10 ppm O 2 Maximum             11. _____ppm                                     9.Analyzer Tag Number                                             12.DETECTPR TUBE        ___          10 ppm CO Maximum          14. _____ppm CARBON                         INFARED ANALYZER   ___              Expiration Date of Tube       15. ______ MONOXIDE                                                                         Lot Number of Tube            16. ______                                     13. Analyzer Tag Number ODOR                         Organoleptic (Nasal)                           None                                       17. ______ N.F. applies only when used in a medical application or by medical customers properly registered with the FDA. * Plus inerts 18. Analyzed By         ________________________            Date ____________ 19. Does this lot require additional testing?  ___ NO            ___ YES – attach page 2 20. SQCU Review/Release _______________________     Date ____________ MANDATORY FORM User must assure that this revision of the form is current prior to use. Completed forms become permanent records subject to the record retention policy.


Medication Information

Description

AIR LIQUIDE  NITROGEN N.F.        Form Number: 2A-ALL-QUA-0003-F                                                             Revision:         0                                                             Effective Date: 03/02/06                                                             Page:               1/1 CERTIFICATE OF ANALYSIS Air Liquide large Industries U.S. L.P. – Houston, TX 77056 PRODUCED BY AIR LIQUEFACTION 1.Location       Street Address1                                  2. Carrier ________________ Street Address 2 City, State Zip 3. Lot Number ______________________                4. Trailer No _____________ PRE-FILL REPORT                                                   FILL REPORT 5.Residual Assay        6. Odor                                    7. Trailer loaded with appropriate product per appropriate    (≤10 ppm O 2 )                Detected                                 loading procedure by:    _______ ppm              Yes    No                              Signature _________________________    ________                    ________                             Date _____________________________     Initial                            Initial ANALYSIS REPORT Test required               Method of Analysis                             Specifications                         Results ASSAY AND               8.PARAMAGNETIC       ___               99.998% N 2 Minimum*           10. ____% IDENTIFICATION         MICROFUEL CELL    ___                                   ELECTROCHEMICAL ___                                                CELL                                           10 ppm O 2 Maximum             11. _____ppm                                     9.Analyzer Tag Number                                             12.DETECTPR TUBE        ___          10 ppm CO Maximum          14. _____ppm CARBON                         INFARED ANALYZER   ___              Expiration Date of Tube       15. ______ MONOXIDE                                                                         Lot Number of Tube            16. ______                                     13. Analyzer Tag Number ODOR                         Organoleptic (Nasal)                           None                                       17. ______ N.F. applies only when used in a medical application or by medical customers properly registered with the FDA. * Plus inerts 18. Analyzed By         ________________________            Date ____________ 19. Does this lot require additional testing?  ___ NO            ___ YES – attach page 2 20. SQCU Review/Release _______________________     Date ____________ MANDATORY FORM User must assure that this revision of the form is current prior to use. Completed forms become permanent records subject to the record retention policy.

Nitrogen N.f. Coa

AIR LIQUIDE  NITROGEN N.F.        Form Number: 2A-ALL-QUA-0003-F

                                                            Revision:         0

                                                            Effective Date: 03/02/06

                                                            Page:               1/1

CERTIFICATE OF ANALYSIS

Air Liquide large Industries U.S. L.P. – Houston, TX 77056

PRODUCED BY AIR LIQUEFACTION

1.Location       Street Address1                                  2. Carrier ________________

Street Address 2

City, State Zip

3. Lot Number ______________________                4. Trailer No _____________

PRE-FILL REPORT                                                   FILL REPORT

5.Residual Assay        6. Odor                                    7. Trailer loaded with appropriate product per appropriate

   (≤10 ppm O2)                Detected                                 loading procedure by:

   _______ ppm              Yes    No                              Signature _________________________

   ________                    ________                             Date _____________________________

    Initial                            Initial

ANALYSIS REPORT

Test required               Method of Analysis                             Specifications                         Results

ASSAY AND               8.PARAMAGNETIC       ___               99.998% N2 Minimum*           10. ____%

IDENTIFICATION         MICROFUEL CELL    ___

                                  ELECTROCHEMICAL ___            

                                   CELL                                           10 ppm O2 Maximum             11. _____ppm

                                    9.Analyzer Tag Number        

                                    12.DETECTPR TUBE        ___          10 ppm CO Maximum          14. _____ppm

CARBON                         INFARED ANALYZER   ___              Expiration Date of Tube       15. ______

MONOXIDE                                                                         Lot Number of Tube            16. ______

                                    13. Analyzer Tag Number

ODOR                         Organoleptic (Nasal)                           None                                       17. ______

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

* Plus inerts

18. Analyzed By         ________________________            Date ____________

19. Does this lot require additional testing?  ___ NO            ___ YES – attach page 2

20. SQCU Review/Release _______________________     Date ____________

MANDATORY FORM

User must assure that this revision of the form is current prior to use. Completed forms become permanent records subject to the record retention policy.


Structured Label Content

Nitrogen N.f. Coa (Nitrogen N.F. COA)

AIR LIQUIDE  NITROGEN N.F.        Form Number: 2A-ALL-QUA-0003-F

                                                            Revision:         0

                                                            Effective Date: 03/02/06

                                                            Page:               1/1

CERTIFICATE OF ANALYSIS

Air Liquide large Industries U.S. L.P. – Houston, TX 77056

PRODUCED BY AIR LIQUEFACTION

1.Location       Street Address1                                  2. Carrier ________________

Street Address 2

City, State Zip

3. Lot Number ______________________                4. Trailer No _____________

PRE-FILL REPORT                                                   FILL REPORT

5.Residual Assay        6. Odor                                    7. Trailer loaded with appropriate product per appropriate

   (≤10 ppm O2)                Detected                                 loading procedure by:

   _______ ppm              Yes    No                              Signature _________________________

   ________                    ________                             Date _____________________________

    Initial                            Initial

ANALYSIS REPORT

Test required               Method of Analysis                             Specifications                         Results

ASSAY AND               8.PARAMAGNETIC       ___               99.998% N2 Minimum*           10. ____%

IDENTIFICATION         MICROFUEL CELL    ___

                                  ELECTROCHEMICAL ___            

                                   CELL                                           10 ppm O2 Maximum             11. _____ppm

                                    9.Analyzer Tag Number        

                                    12.DETECTPR TUBE        ___          10 ppm CO Maximum          14. _____ppm

CARBON                         INFARED ANALYZER   ___              Expiration Date of Tube       15. ______

MONOXIDE                                                                         Lot Number of Tube            16. ______

                                    13. Analyzer Tag Number

ODOR                         Organoleptic (Nasal)                           None                                       17. ______

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

* Plus inerts

18. Analyzed By         ________________________            Date ____________

19. Does this lot require additional testing?  ___ NO            ___ YES – attach page 2

20. SQCU Review/Release _______________________     Date ____________

MANDATORY FORM

User must assure that this revision of the form is current prior to use. Completed forms become permanent records subject to the record retention policy.


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