Ventlab BT2016
Ventlab BT2016 is a Class I device made by Ventlab Corp., cleared under FDA 510(k) K953107 on 15 Aug 1995 and listed in FDA GUDID since 20 Nov 2016 (UDI-DI 10889483097830), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10889483097830 | Date20 Nov 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK953107 | Date15 Aug 1995 | StatusActive |
Official records
- AccessGUDID record 10889483097830
- FDA 510(k) database K953107
Across registries
- FDA 510(k) K953107 decided 15 Aug 1995 Active
- FDA GUDID UDI-DI 10889483097830 listed 20 Nov 2016 Listed
Timeline
- Cleared FDA 510(k) K953107
- Listed FDA GUDID 10889483097830
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Ventlab
- Generic name
- Pulmonary resuscitator, manual, single-use
- Model / reference
- BT2016
- Primary DI / UDI-DI
- 10889483097830
- FDA product code
- BSJ
- GMDN term
- Pulmonary resuscitator, manual, single-use
- Device class
- Class I
- Regulation number
- 868.5550
- GUDID distribution status
- In Commercial Distribution
- Size
- Total Volume — 300 Milliliter
Similar devices in this category
Other devices filed under Pulmonary resuscitator, manual, single-use.
- Pocket BVM™ Manual Resuscitator by Micro BVM Systems Ltd
- Pocket BVM™ Manual Resuscitator with O2 tubing by Micro BVM Systems Ltd
- FlowSense A0000047 by ARCHEON
- Flexicare 038-72-982U by FLEXICARE MEDICAL LIMITED
- Manual Resuscitators HY-005-02 by Ningbo Hanyue Medical Technology CO.,LTD.
- Silicone Resuscitator 1610-0003 by FORTUNE MEDICAL INSTRUMENT CORP.
- Manual Resuscitator S-660-03-EN by VADI Medical Technology Co., Ltd.
- PLASTI-MED 536040 by Plasti-med Plastik Medikal Ürünler San. ve Tic. Ltd. Şti.