Ventlab BT2007
Ventlab BT2007 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 10889483092408), 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 | Number10889483092408 | Date20 Nov 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK953107 | Date15 Aug 1995 | StatusActive |
Official records
- AccessGUDID record 10889483092408
- FDA 510(k) database K953107
Across registries
- FDA 510(k) K953107 decided 15 Aug 1995 Active
- FDA GUDID UDI-DI 10889483092408 listed 20 Nov 2016 Listed
Timeline
- Cleared FDA 510(k) K953107
- Listed FDA GUDID 10889483092408
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- Withdrawn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
- BT2007
- Primary DI / UDI-DI
- 10889483092408
- 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
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