| Primary Device ID | 00819601020146 |
| NIH Device Record Key | 33e3280b-3816-416e-9caf-3280e0a7f872 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VITARA BIOMEDICAL |
| Version Model Number | Calibration Gas |
| Catalog Number | Z03NI904YDC000 |
| Company DUNS | 118537769 |
| Company Name | Airgas Therapeutics, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Pressure | 2000 Pound per Square Inch |
| Total Volume | 94 Liter |
| Pressure | 2000 Pound per Square Inch |
| Total Volume | 94 Liter |
| Pressure | 2000 Pound per Square Inch |
| Total Volume | 94 Liter |
| Pressure | 2000 Pound per Square Inch |
| Total Volume | 94 Liter |
| Pressure | 2000 Pound per Square Inch |
| Total Volume | 94 Liter |
| Pressure | 2000 Pound per Square Inch |
| Total Volume | 94 Liter |
| Pressure | 2000 Pound per Square Inch |
| Total Volume | 94 Liter |
| Pressure | 2000 Pound per Square Inch |
| Total Volume | 94 Liter |
| Pressure | 2000 Pound per Square Inch |
| Total Volume | 94 Liter |
| Pressure | 2000 Pound per Square Inch |
| Total Volume | 94 Liter |
| Pressure | 2000 Pound per Square Inch |
| Total Volume | 94 Liter |
| Pressure | 2000 Pound per Square Inch |
| Total Volume | 94 Liter |
| Pressure | 2000 Pound per Square Inch |
| Total Volume | 94 Liter |
| Pressure | 2000 Pound per Square Inch |
| Total Volume | 94 Liter |
| Pressure | 2000 Pound per Square Inch |
| Total Volume | 94 Liter |
| Pressure | 2000 Pound per Square Inch |
| Total Volume | 94 Liter |
| Pressure | 2000 Pound per Square Inch |
| Total Volume | 94 Liter |
| Storage Environment Temperature | Between 0 Degrees Celsius and 52 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 52 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 52 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 52 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 52 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 52 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 52 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 52 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 52 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 52 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 52 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 52 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 52 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 52 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 52 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 52 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 52 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00819601020146 [Primary] |
| BXK | Gas, Calibration (Specified Concentration) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-12-15 |
| Device Publish Date | 2023-12-07 |
| 00819601025721 - SIEMENS HEALTHCARE | 2025-06-30 Description: 42% CO2, 15% O2, BAL. N2; Cylinder: K; Valve: CGA 500; For calibration of medical analyzers in accordance with ma |
| 00819601025738 - SIEMENS HEALTHCARE | 2025-06-30 Description: 43% CO2, 15% O2, BAL. N2; Cylinder: K; Valve: CGA 500; For calibration of medical analyzers in accordance with ma |
| 00819601025745 - BVI Medical | 2025-06-16 ISPAN Single Stage Regulator; CGA 180; For BVI |
| 00819601025752 - BVI Medical | 2025-06-16 ISPAN Dual Stage Regulator; CGA 180; For BVI |
| 00819601025653 - Scott Medical Products | 2025-05-30 Description: 5% CO2, 15% O2, BAL. N2; Cylinder: K; Valve: CGA 500; For calibration of medical analyzers in accordance with man |
| 10819601025667 - BVI Medical | 2025-05-28 ISPAN Gas, Sulfur Hexafluoride (SF6); Cylinder: LD1; Valve: CGA 180; Retinal tamponade for use in pneumatic retinopexy. |
| 10819601025674 - BVI Medical | 2025-05-28 ISPAN Gas, Sulfur Hexafluoride (SF6); Cylinder: LD2; Valve: CGA 180; Retinal tamponade for use in pneumatic retinopexy. |
| 10819601025681 - BVI Medical | 2025-05-28 ISPAN Gas, Sulfur Hexafluoride (SF6); Cylinder: LD2; Valve: CGA 170; Retinal tamponade for use in pneumatic retinopexy. |