Idkit: Hp One AC00051
by Meridian Bioscience Israel Ltd
Idkit: Hp One AC00051 is a gas sampling line filter made by Meridian Bioscience Israel Ltd, cleared under FDA 510(k) K173772 on 8 Mar 2018 and listed in FDA GUDID since 15 Dec 2021 (UDI-DI 00350402100137), 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 | Number00350402100137 | Date15 Dec 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK173772 | Date8 Mar 2018 | StatusActive |
Official records
- AccessGUDID record 00350402100137
- FDA 510(k) database K173772
Across registries
- FDA 510(k) K173772 decided 8 Mar 2018 Active
- FDA GUDID UDI-DI 00350402100137 listed 15 Dec 2021 Listed
Timeline
- Cleared FDA 510(k) K173772
- Listed FDA GUDID 00350402100137
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Idkit: Hp One
- Generic name
- Gas sampling line filter, single-use
- Model / reference
- AC00051
- Primary DI / UDI-DI
- 00350402100137
- 510(k) Number
- GMDN term
- Gas sampling line filter, single-use
- GUDID distribution status
- In Commercial Distribution
- Size
- Height — 280 MillimeterWidth — 186 MillimeterDepth — 156 Millimeter