GE Healthcare Z03OX62MUDC000
GUDID 00819601025424
Description: 8% SEVOFLURANE, 30% N2O, BAL. O2; Cylinder: UD; Valve: CGA 165; For calibration of medical analyzers in accordance with manufacturer's instructions.
Airgas Therapeutics, LLC
Calibration gas/non-refillable cylinder| Primary Device ID | 00819601025424 |
| NIH Device Record Key | 91e592ae-e01b-45b8-ad4a-72f463117a3a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GE Healthcare |
| Version Model Number | Calibration Gas |
| Catalog Number | Z03OX62MUDC000 |
| 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 |
Customer Support Contacts
Device Dimensions
| Total Volume | 12 Liter |
| Pressure | 8 Pound per Square Inch |
| Total Volume | 12 Liter |
| Pressure | 8 Pound per Square Inch |
| Total Volume | 12 Liter |
| Pressure | 8 Pound per Square Inch |
| Total Volume | 12 Liter |
| Pressure | 8 Pound per Square Inch |
| Total Volume | 12 Liter |
| Pressure | 8 Pound per Square Inch |
| Total Volume | 12 Liter |
| Pressure | 8 Pound per Square Inch |
| Total Volume | 12 Liter |
| Pressure | 8 Pound per Square Inch |
| Total Volume | 12 Liter |
| Pressure | 8 Pound per Square Inch |
| Total Volume | 12 Liter |
| Pressure | 8 Pound per Square Inch |
| Total Volume | 12 Liter |
| Pressure | 8 Pound per Square Inch |
| Total Volume | 12 Liter |
| Pressure | 8 Pound per Square Inch |
| Total Volume | 12 Liter |
| Pressure | 8 Pound per Square Inch |
| Total Volume | 12 Liter |
| Pressure | 8 Pound per Square Inch |
| Total Volume | 12 Liter |
| Pressure | 8 Pound per Square Inch |
| Total Volume | 12 Liter |
| Pressure | 8 Pound per Square Inch |
| Total Volume | 12 Liter |
| Pressure | 8 Pound per Square Inch |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Celsius and 52 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 52 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 52 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 52 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 52 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 52 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 52 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 52 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 52 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 52 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 52 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 52 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 52 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 52 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 52 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 52 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 0 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00819601025424 [Primary] |
FDA Product Code
| BXK | Gas, Calibration (Specified Concentration) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-12 |
| Device Publish Date | 2024-08-02 |
On-Brand Devices [GE Healthcare]
| 00819601025431 | Description: 8% SEVOFLURANE, BAL. AIR; Cylinder: UD; Valve: CGA 165; For calibration of medical |
| 00819601025424 | Description: 8% SEVOFLURANE, 30% N2O, BAL. O2; Cylinder: UD; Valve: CGA 165; For calibration o |
| 00819601025417 | Description: 8% SEVOFLURANE, BAL. O2; Cylinder: UD; Valve: CGA 165; For calibration of medical |
| 00819601025400 | Description: 7.64% Sevoflurane, 75% N2O, BAL. O2; Cylinder: UD; Valve: CGA 165; For calibratio |
Trademark Results [GE Healthcare]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GE HEALTHCARE 97537319 not registered Live/Pending |
General Electric Company 2022-08-05 |
 GE HEALTHCARE 97536608 not registered Live/Pending |
General Electric Company 2022-08-05 |
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