Oxygen

Oxygen
SPL v7
SPL
SPL Set ID d130e778-a02c-4762-b09a-85358e0994ce
Route
RESPIRATORY (INHALATION)
Published
Effective Date 2024-10-27
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxygen (99 L)

Identifiers & Packaging

Marketing Status
NDA Active Since 2017-12-27

Description

Certificate of Analysis                    Shipped From:                                                                                                                 Ashtabula Oxygen                                                                                                                 2501 Middle Rd.                                                                                                                 Ashtabula, Ohio                                                                                                                                               Phone: (440) 994-1994 Company Name: TEST Product:               Oxygen Load No:              6                                                                                              Trailer No:          0000 Time In:               16:56:01               Time Out:            16:56:38               Load Date:          12/26/2017 Tare Weight:     0                              Gross Weight:   0           lbs           Net Weight:       0    lbs Lot Number:      4004O17360060000                                         Produced by: Air Liquefaction Ashtabula Oxygen Results Units Specifications Purity Pre-Fill:                  PASS                                                                      Pass* Purity Post-Fill:                99.99                     %                            >=99.6% Assay, Tested By: Teledyne 3010MA Paramagnetic The Pre-Fill is tested against Ashtabula Oxygen and USP/NF specification and a “Pass” indicated that the results met and exceeded the applicable specifications. The results of the Pre-Fill tests are kept on file. Ashtabula Oxygen Analyst: I declare that this analysis was completed with all Ashtabula Oxygen policy and procedures and that the product meets all Ashtabula Oxygen and USP/NF specifications. Signed:         Date/Time: Product Release Specialist/Release By: I declare that this certification is accurate, complete and compliant with all applicable policies and procedures and that the product meets all Ashtabula Oxygen and USP/NF specifications. Signed:         Date/Time: 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 MSDS. Signed:         Date/Time:                                                                                                                                                                 TF-0001-O Rev.1


Medication Information

Description

Certificate of Analysis                    Shipped From:                                                                                                                 Ashtabula Oxygen                                                                                                                 2501 Middle Rd.                                                                                                                 Ashtabula, Ohio                                                                                                                                               Phone: (440) 994-1994 Company Name: TEST Product:               Oxygen Load No:              6                                                                                              Trailer No:          0000 Time In:               16:56:01               Time Out:            16:56:38               Load Date:          12/26/2017 Tare Weight:     0                              Gross Weight:   0           lbs           Net Weight:       0    lbs Lot Number:      4004O17360060000                                         Produced by: Air Liquefaction Ashtabula Oxygen Results Units Specifications Purity Pre-Fill:                  PASS                                                                      Pass* Purity Post-Fill:                99.99                     %                            >=99.6% Assay, Tested By: Teledyne 3010MA Paramagnetic The Pre-Fill is tested against Ashtabula Oxygen and USP/NF specification and a “Pass” indicated that the results met and exceeded the applicable specifications. The results of the Pre-Fill tests are kept on file. Ashtabula Oxygen Analyst: I declare that this analysis was completed with all Ashtabula Oxygen policy and procedures and that the product meets all Ashtabula Oxygen and USP/NF specifications. Signed:         Date/Time: Product Release Specialist/Release By: I declare that this certification is accurate, complete and compliant with all applicable policies and procedures and that the product meets all Ashtabula Oxygen and USP/NF specifications. Signed:         Date/Time: 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 MSDS. Signed:         Date/Time:                                                                                                                                                                 TF-0001-O Rev.1

Oxygen Coa

Certificate of Analysis                    Shipped From:

                                                                                                                Ashtabula Oxygen

                                                                                                                2501 Middle Rd.

                                                                                                                Ashtabula, Ohio                              

                                                                                                                Phone: (440) 994-1994

Company Name: TEST

Product:               Oxygen

Load No:              6                                                                                              Trailer No:          0000

Time In:               16:56:01               Time Out:            16:56:38               Load Date:          12/26/2017

Tare Weight:     0                              Gross Weight:   0           lbs           Net Weight:       0    lbs

Lot Number:      4004O17360060000                                         Produced by: Air Liquefaction

Ashtabula Oxygen

Results Units Specifications

Purity Pre-Fill:                  PASS                                                                      Pass*

Purity Post-Fill:                99.99                     %                            >=99.6%

Assay, Tested By: Teledyne 3010MA Paramagnetic

  • The Pre-Fill is tested against Ashtabula Oxygen and USP/NF specification and a “Pass” indicated that the results met and exceeded the applicable specifications. The results of the Pre-Fill tests are kept on file.

Ashtabula Oxygen Analyst: I declare that this analysis was completed with all Ashtabula Oxygen policy and procedures and that the product meets all Ashtabula Oxygen and USP/NF specifications.

Signed:         Date/Time:

Product Release Specialist/Release By: I declare that this certification is accurate, complete and compliant with all applicable policies and procedures and that the product meets all Ashtabula Oxygen and USP/NF specifications.

Signed:         Date/Time:

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 MSDS.

Signed:         Date/Time:

                                                                                                                                                                TF-0001-O Rev.1


Structured Label Content

Oxygen Coa (Oxygen COA)

Certificate of Analysis                    Shipped From:

                                                                                                                Ashtabula Oxygen

                                                                                                                2501 Middle Rd.

                                                                                                                Ashtabula, Ohio                              

                                                                                                                Phone: (440) 994-1994

Company Name: TEST

Product:               Oxygen

Load No:              6                                                                                              Trailer No:          0000

Time In:               16:56:01               Time Out:            16:56:38               Load Date:          12/26/2017

Tare Weight:     0                              Gross Weight:   0           lbs           Net Weight:       0    lbs

Lot Number:      4004O17360060000                                         Produced by: Air Liquefaction

Ashtabula Oxygen

Results Units Specifications

Purity Pre-Fill:                  PASS                                                                      Pass*

Purity Post-Fill:                99.99                     %                            >=99.6%

Assay, Tested By: Teledyne 3010MA Paramagnetic

  • The Pre-Fill is tested against Ashtabula Oxygen and USP/NF specification and a “Pass” indicated that the results met and exceeded the applicable specifications. The results of the Pre-Fill tests are kept on file.

Ashtabula Oxygen Analyst: I declare that this analysis was completed with all Ashtabula Oxygen policy and procedures and that the product meets all Ashtabula Oxygen and USP/NF specifications.

Signed:         Date/Time:

Product Release Specialist/Release By: I declare that this certification is accurate, complete and compliant with all applicable policies and procedures and that the product meets all Ashtabula Oxygen and USP/NF specifications.

Signed:         Date/Time:

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 MSDS.

Signed:         Date/Time:

                                                                                                                                                                TF-0001-O Rev.1


Advanced Ingredient Data


Raw Label Data

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