Identity
- Trade Name
- POC-AS10 Auto sampler FDA UDI
- Generic Name
- Infrared spectrometry breath analyser IVD FDA UDI
- Device Name
- The POC-ASI10 Auto sampler expands the number of breath collection bags that can be set up and analyzed by the POCone Infrared Spectrophotometer. FDA UDI
- Model / Reference
- POC-AS10 FDA UDI
- Description
- The POC-ASI10 Auto sampler expands the number of breath collection bags that can be set up and analyzed by the POCone Infrared Spectrophotometer. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987035388517 FDA UDI
- 510(k) Number
- K092817 FDA UDI
- FDA Product Code
- JJQ FDA UDI
- GMDN Term
- Infrared spectrometry breath analyser IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Infrared spectrometry breath analyser IVD
POC-AS10 Auto sampler by Otsuka Electronics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Infrared spectrometry breath analyser IVD.
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- Auto Sampler (for BreathID Hp Lab System) — MERIDIAN BIOSCIENCE ISRAEL LTD · Class I
- BreathID Hp Lab Device (WIN) — MERIDIAN BIOSCIENCE ISRAEL LTD · Class I
- BreathID Hp Lab Device — MERIDIAN BIOSCIENCE ISRAEL LTD · Class I
- BreathID Smart System — MERIDIAN BIOSCIENCE ISRAEL LTD · Class I
- POCone Infrared Spectrophotometer — Otsuka Electronics · Class I
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 | Class I | Pending data |
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Manufacturer
- Manufacturer
- Otsuka Electronics
Sources (1)
- FDA UDI 65282e18-d712-4813-9d8c-c80d5224c5aa 36 fields · synced May 30, 2026