Identity
- Trade Name
- Bio Trend® FDA UDI
- Generic Name
- Extracorporeal blood gas/pH monitor FDA UDI
- Device Name
- EVAL INST E95198-04 BIOTREND UNIV DOM FDA UDI
- Model / Reference
- E95198-04 FDA UDI
- Description
- EVAL INST E95198-04 BIOTREND UNIV DOM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00613994750280 FDA UDI
- 510(k) Number
- K093650 FDA UDI
- FDA Product Code
- DTY FDA UDI
- GMDN Term
- Extracorporeal blood gas/pH monitor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4410 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Extracorporeal blood gas/pH monitor
Bio Trend® by Medtronic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K093650 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
- Medtronic, Inc.
Sources (1)
- FDA UDI d8822104-c299-4e9d-8240-6e8fb8d6471e 36 fields · synced May 30, 2026