BiTrac HC 313-9413
BiTrac HC 313-9413 is a Class II device made by Pulmodyne Inc., cleared under FDA 510(k) K972605 on 28 Jan 1998 and listed in FDA GUDID since 28 Oct 2016 (UDI-DI 00841470107628), active as of 22 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 | Number00841470107628 | Date28 Oct 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK972605 | Date28 Jan 1998 | StatusActive |
Official records
- AccessGUDID record 00841470107628
- FDA 510(k) database K972605
Across registries
- FDA 510(k) K972605 decided 28 Jan 1998 Active
- FDA GUDID UDI-DI 00841470107628 listed 28 Oct 2016 Listed
Timeline
- Cleared FDA 510(k) K972605
- Listed FDA GUDID 00841470107628
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- BiTrac HC
- Generic name
- CPAP/BPAP nasal mask, single-use
- Model / reference
- 313-9413
- Primary DI / UDI-DI
- 00841470107628
- 510(k) Number
- FDA product code
- BZD
- GMDN term
- CPAP/BPAP nasal mask, single-use
- Device class
- Class II
- Regulation number
- 868.5905
- GUDID distribution status
- In Commercial Distribution
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