Identity
- Trade Name
- EasyBloodGas Analyzer FDA UDI
- Generic Name
- Blood gas analyser IVD, laboratory FDA UDI
- Device Name
- EasyBloodGas Analyzer FDA UDI
- Model / Reference
- 6001 FDA UDI
- Description
- EasyBloodGas Analyzer FDA UDI
Identifiers
- Catalog Number
- 6001 FDA UDI
- Primary DI / UDI-DI
- 00386100002299 FDA UDI
- 510(k) Number
- K974526 FDA UDI
- FDA Product Code
- CHL FDA UDI
- GMDN Term
- Blood gas analyser IVD, laboratory FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1120 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
Yes
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Blood gas analyser IVD, laboratory
EasyBloodGas Analyzer by Medica Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Blood gas analyser IVD, laboratory.
Cleared under the same submission
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
- Medica Corp.
Sources (1)
- FDA UDI be7ac9c9-74ca-47c1-83c7-191c991c5c57 37 fields · synced May 30, 2026