Masimo Z03NI90MUDC001
GUDID 00819601025110
Description: 5% ISOFLURANE, 5% CO2, BAL. N2; Cylinder: UD; Valve: CGA 165; For calibration of medical analyzers in accordance with manufacturer's instructions.
Airgas Therapeutics, LLC
Calibration gas/non-refillable cylinder Calibration gas/non-refillable cylinder Calibration gas/non-refillable cylinder Calibration gas/non-refillable cylinder Calibration gas/non-refillable cylinder Calibration gas/non-refillable cylinder Calibration gas/non-refillable cylinder Calibration gas/non-refillable cylinder Calibration gas/non-refillable cylinder Calibration gas/non-refillable cylinder Calibration gas/non-refillable cylinder Calibration gas/non-refillable cylinder Calibration gas/non-refillable cylinder Calibration gas/non-refillable cylinder Calibration gas/non-refillable cylinder Calibration gas/non-refillable cylinder Calibration gas/non-refillable cylinder| Primary Device ID | 00819601025110 |
| NIH Device Record Key | 044655e2-f335-4e93-9c12-ee8f9b7cd397 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Masimo |
| Version Model Number | Anesthesia Calibration Gas |
| Catalog Number | Z03NI90MUDC001 |
| 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 | 65 Liter |
| Pressure | 46 Pound per Square Inch |
| Total Volume | 65 Liter |
| Pressure | 46 Pound per Square Inch |
| Total Volume | 65 Liter |
| Pressure | 46 Pound per Square Inch |
| Total Volume | 65 Liter |
| Pressure | 46 Pound per Square Inch |
| Total Volume | 65 Liter |
| Pressure | 46 Pound per Square Inch |
| Total Volume | 65 Liter |
| Pressure | 46 Pound per Square Inch |
| Total Volume | 65 Liter |
| Pressure | 46 Pound per Square Inch |
| Total Volume | 65 Liter |
| Pressure | 46 Pound per Square Inch |
| Total Volume | 65 Liter |
| Pressure | 46 Pound per Square Inch |
| Total Volume | 65 Liter |
| Pressure | 46 Pound per Square Inch |
| Total Volume | 65 Liter |
| Pressure | 46 Pound per Square Inch |
| Total Volume | 65 Liter |
| Pressure | 46 Pound per Square Inch |
| Total Volume | 65 Liter |
| Pressure | 46 Pound per Square Inch |
| Total Volume | 65 Liter |
| Pressure | 46 Pound per Square Inch |
| Total Volume | 65 Liter |
| Pressure | 46 Pound per Square Inch |
| Total Volume | 65 Liter |
| Pressure | 46 Pound per Square Inch |
| Total Volume | 65 Liter |
| Pressure | 46 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 |
| 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 | 00819601025110 [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 | 2023-07-17 |
| Device Publish Date | 2023-07-08 |
Devices Manufactured by Airgas Therapeutics, LLC
| 00819601020214 - Siemens | 2024-04-29 Description: 28% CO2, 1.4% O2, BAL. N2 - PGS; Cylinder: 300; Valve: CGA 500; For calibration of medical analyzers in accordanc |
| 00819601020955 - Siemens | 2024-04-29 Description: 0.7% CO2, 98.2% O2, BAL. N2 - PGS; Cylinder: 300; Valve: CGA 500; For calibration of medical analyzers in accordan |
| 00819601020962 - Siemens | 2024-04-29 Description: 6.3% CO2, 28% O2, BAL. N2 - PGS; Cylinder: 300; Valve: CGA 500; For calibration of medical analyzers in accordance |
| 00819601020979 - Siemens | 2024-04-29 Description: 4.9% CO2, 7.7% O2, BAL. N2 - PGS; Cylinder: 300; Valve: CGA 500; For calibration of medical analyzers in accordanc |
| 00819601020191 - Scott Medical Products | 2024-04-01 Description: 1% ISO, 2% SEVO, 5% CO2, 70% N2O/O2; Cylinder: SD; Valve: CGA 600; For calibration of medical analyzers in accord |
| 00819601020153 - Scott Medical Products | 2024-03-29 Description: 21% O2, BAL. N2; Cylinder: ED; Valve: CGA 973; For calibration of medical analyzers in accordance with manufactur |
| 00819601020160 - Scott Medical Products | 2024-03-29 Description: 5% CO2, 20% O2, BAL. N2; Cylinder: ED; Valve: CGA 973; For calibration of medical analyzers in accordance with ma |
| 00819601020177 - Scott Medical Products | 2024-03-29 Description: 0.3% CO, 0.3% CH4, 21% O2/N2; Cylinder: ED; Valve: CGA 973; For use with Pulmonary Function Diagnostic Equipment i |
Trademark Results [Masimo]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MASIMO 97143317 not registered Live/Pending |
Jens Hubenthal 2021-11-25 |
 MASIMO 90053030 not registered Live/Pending |
Masimo Corporation 2020-07-15 |
 MASIMO 85034302 not registered Dead/Abandoned |
Delicato Vineyards 2010-05-10 |
 MASIMO 78869381 3249261 Live/Registered |
CAPORI USA INC. 2006-04-25 |
 MASIMO 74442460 1906425 Live/Registered |
MASIMO CORPORATION 1993-09-30 |
 MASIMO 74323652 1951663 Live/Registered |
MASIMO CORPORATION 1992-10-16 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.