Horizon Series™ PF96h
by HELMER Inc.
Horizon Series™ PF96h is a Class I device made by HELMER Inc., listed in FDA GUDID since 1 Jul 2016 (UDI-DI 00816394020841), registry data as of 22 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00816394020841 | Date1 Jul 2016 | StatusListed |
Official records
- AccessGUDID record 00816394020841
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Horizon Series™
- Generic name
- Platelet agitator
- Model / reference
- PF96h
- Primary DI / UDI-DI
- 00816394020841
- FDA product code
- KSQ
- GMDN term
- Platelet agitator
- Device class
- Class I
- Regulation number
- 864.9195
- GUDID distribution status
- In Commercial Distribution
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