Ventlab
GUDID 20889483104474
PEDIATRIC BAG,3 MASK, INFLATABLE O2RESERVOIR,POP-OFF,SAL.TUB.,APT
VENTLAB, LLC
Pulmonary resuscitator, manual, single-use| Primary Device ID | 20889483104474 |
| NIH Device Record Key | 9ad3a018-e87c-413d-9858-b240481bc6d1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ventlab |
| Version Model Number | VN2002MBCHW |
| Company DUNS | 038305402 |
| Company Name | VENTLAB, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 800-433-2797 |
| info@sun-med.com | |
| Phone | 800-433-2797 |
| info@sun-med.com |
Device Dimensions
| Total Volume | 1000 Milliliter |
| Total Volume | 1000 Milliliter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. Do not get wet. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. Do not get wet. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10889483104477 [Primary] |
| GS1 | 20889483104474 [Package] Contains: 10889483104477 Package: Box [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K953546
FDA Product Code
| BTM | Ventilator, Emergency, Manual (Resuscitator) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-10-21 |
| Device Publish Date | 2016-12-03 |
Devices Manufactured by VENTLAB, LLC
| 30889483631526 - AirFlow™ | 2025-02-11 AirFlow™ Pediatric Resuscitator with Integrated Manometer, 40cm Pop-Off, Corrugated Tubing, 3 Masks and PEEP Valve |
| 30889483631533 - AirFlow™ | 2025-02-10 AirFlow™ Adult Resuscitator with Integrated Manometer, 40cm Pop-Off, Corrugated Tubing and PEEP Valve |
| 10889483555675 - Ventlab | 2024-03-20 AirFlow Pediatric Resuscitator with Integrated Manometer, B/V Filter, 40cm Pop-Off, Bag Reservoir, Gas Sampling Line, and Size 5 |
| 10889483555682 - Ventlab | 2024-03-20 AirFlow Adult Resuscitator with Bag Reservoir, Gas Sampling Line, and Mask |
| 10889483555699 - Ventlab | 2024-03-20 AirFlow Adult Resuscitator with B/V Filter, Bag Reservoir, Gas Sampling Line, and Mask |
| 10889483555705 - Ventlab | 2024-03-20 AirFlow Adult Resuscitator with B/V Filter, Bag Reservoir, Mask, PEEP Valve, and Gas Sampling Line |
| 10889483555712 - Ventlab | 2024-03-20 AirFlow Adult Resuscitator with Integrated Manometer, B/V Filter, Bag Reservoir, Gas Sampling Line, and Mask |
| 10889483555729 - Ventlab | 2024-03-20 AirFlow Adult Resuscitator with Integrated Manometer, B/V Filter, Bag Reservoir, Mask, PEEP Valve, and Gas Sampling Line |
Trademark Results [Ventlab]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VENTLAB 76431033 2763787 Live/Registered |
VENTLAB, LLC 2002-07-12 |
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