Identity
- Trade Name
- IDKIT: HP ONE FDA UDI
- Generic Name
- Gas sampling line filter, single-use FDA UDI
- Device Name
- The IDKIT: HP ONE contain 25 units of ID Circuit (cannula). The ID Circuit is used to collect the breath sample from the patient. FDA UDI
- Model / Reference
- AC00051 FDA UDI
- Description
- The IDKIT: HP ONE contain 25 units of ID Circuit (cannula). The ID Circuit is used to collect the breath sample from the patient. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00350402100137 FDA UDI
- 510(k) Number
- K173772 FDA UDI
- GMDN Term
- Gas sampling line filter, single-use FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Height — 280 Millimeter FDA UDIWidth — 186 Millimeter FDA UDIDepth — 156 Millimeter FDA UDI
Category: Gas sampling line filter, single-use
Idkit: Hp One by Meridian Bioscience Israel Ltd — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
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Manufacturer
- Manufacturer
- Meridian Bioscience Israel Ltd
Sources (1)
- FDA UDI 43e5b6ba-8db6-4313-8b56-2725e5c2b75a 36 fields · synced May 30, 2026