Z Vent
GUDID 00847946024185
MAIN ASSEMBLY, VENTILATOR, COMMERCIAL, ZVENT, MRI ADVANCED
Zoll Medical Corporation
Transport electric ventilator| Primary Device ID | 00847946024185 |
| NIH Device Record Key | aee4b6b2-06ee-4815-8aac-7d757a35c528 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Z Vent |
| Version Model Number | 799-EMBP-05-01 |
| Company DUNS | 055363428 |
| Company Name | Zoll Medical Corporation |
| 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 | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00847946024185 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K111473
FDA Product Code
| DQA | Oximeter |
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 | 2020-10-30 |
| Device Publish Date | 2020-10-22 |
On-Brand Devices [Z Vent]
| 00847946024208 | MAIN ASSEMBLY, VENTILATOR, COMMERCIAL, ZVENT, ADVANCED |
| 00847946024192 | MAIN ASSEMBLY, VENTILATOR, COMMERCIAL, ZVENT, BASIC |
| 00847946026592 | MAIN ASSEMBLY, VENTILATOR, COMMERCIAL, ZVENT, ADVANCED |
| 00847946024185 | MAIN ASSEMBLY, VENTILATOR, COMMERCIAL, ZVENT, MRI ADVANCED |
| 00812394023455 | MAIN ASSEMBLY, VENTILATOR, EMV+, MRI, REFURBISHED |
| 00812394023448 | MAIN ASSEMBLY, VENTILATOR, COMMERCIAL, ZVENT, MRI, REFURBISHED |
| 00812394023431 | MAIN ASSEMBLY, VENTILATOR, COMMERCIAL, SW, HOSPITAL CONFIG, REFURBISHED |
| 00812394023424 | MAIN ASSEMBLY, VENTILATOR, COMMERCIAL, ZVENT, REFURBISHED |
| 00812394023417 | DEVICE IDENTIFIER, MAIN ASSEMBLY, VENTILATOR, COMMERCIAL, ZVENT, BASIC, REFURBISHED |
| 00812394023400 | VENTILATOR, EMV+, COMMERCIAL, US, REFURB |
| 00812394023394 | DEVICE IDENTIFIER, VENTILATOR, EMV+, MRI, REFURB |
Trademark Results [Z Vent]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 Z VENT 88252361 5826533 Live/Registered |
ZOLL Medical Corporation 2019-01-07 |
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