Identity
- Trade Name
- epoc Host2 FDA UDI
- Generic Name
- Metabolic profile clinical chemistry analyser IVD FDA UDI
- Device Name
- The epoc Blood Analysis System, is intended for use by trained medical professionals as an in vitro diagnostic device for thequantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory orat the point of care in hospitals, nursing homes or other clinical care institutions. FDA UDI
- Model / Reference
- 11413524 FDA UDI
- Description
- The epoc Blood Analysis System, is intended for use by trained medical professionals as an in vitro diagnostic device for thequantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory orat the point of care in hospitals, nursing homes or other clinical care institutions. FDA UDI
Identifiers
- Catalog Number
- 11413524 FDA UDI
- Primary DI / UDI-DI
- 00630414606460 FDA UDI
- 510(k) Number
- K061597 FDA UDIK090109 FDA UDIK092849 FDA UDIK093297 FDA UDIK113726 FDA UDIK171247 FDA UDI
- FDA Product Code
- JFP FDA UDICHL FDA UDICGA FDA UDIGIO FDA UDIKHP FDA UDIJGS FDA UDICGZ FDA UDIJFL FDA UDICEM FDA UDI
- GMDN Term
- Metabolic profile clinical chemistry analyser IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1145 FDA UDI862.1120 FDA UDI862.1345 FDA UDI864.6150 FDA UDI862.1450 FDA UDI862.1665 FDA UDI862.1170 FDA UDI862.1160 FDA UDI862.1600 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Metabolic profile clinical chemistry analyser IVD
epoc Host2 by Epocal Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K092849 also covers:
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 II | Pending data |
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Manufacturer
- Manufacturer
- Epocal Inc
Sources (1)
- FDA UDI 01480dea-ef90-40c5-b254-02befd49e7dd 37 fields · synced May 30, 2026