Aestiva
GUDID 00840682102339
DATEX-OHMEDA INC
Anaesthesia workstation, general-purpose| Primary Device ID | 00840682102339 |
| NIH Device Record Key | b5e08c50-2ef1-494a-8cd1-bb5b82a56546 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Aestiva |
| Version Model Number | MRI |
| Company DUNS | 129501685 |
| Company Name | DATEX-OHMEDA INC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *magnetic fringe field less than or equal to 300 gauss |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 66 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 49.99 KiloPascal and 106.66 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 66 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 49.99 KiloPascal and 106.66 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 66 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 49.99 KiloPascal and 106.66 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 66 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 49.99 KiloPascal and 106.66 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 66 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 49.99 KiloPascal and 106.66 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 66 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 49.99 KiloPascal and 106.66 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 66 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 49.99 KiloPascal and 106.66 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 66 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 49.99 KiloPascal and 106.66 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 66 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 49.99 KiloPascal and 106.66 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 66 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 49.99 KiloPascal and 106.66 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 66 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 49.99 KiloPascal and 106.66 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 66 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 49.99 KiloPascal and 106.66 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 66 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 49.99 KiloPascal and 106.66 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 66 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 49.99 KiloPascal and 106.66 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 66 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 49.99 KiloPascal and 106.66 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 66 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 49.99 KiloPascal and 106.66 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 66 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 49.99 KiloPascal and 106.66 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 66 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 49.99 KiloPascal and 106.66 KiloPascal |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840682102339 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K050055
FDA Product Code
| BSZ | Gas-machine, anesthesia |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-09-23 |
On-Brand Devices [Aestiva]
| 00840682102339 | MRI |
| 00840682102308 | 7900 |
Trademark Results [Aestiva]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AESTIVA 75349916 2314902 Live/Registered |
DATEX-OHMEDA, INC. 1997-09-02 |
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