Identity
- Trade Name
- AccuTemp Probe FDA UDI
- Generic Name
- Environmental sensor FDA UDI
- Device Name
- OHMEDA GIRAFFE OMNI-BED COMPATIBLE TEMP.PROBE w/hydrogel 175 probe cover FDA UDI
- Model / Reference
- 232H FDA UDI
- Description
- OHMEDA GIRAFFE OMNI-BED COMPATIBLE TEMP.PROBE w/hydrogel 175 probe cover FDA UDI
Identifiers
- Catalog Number
- 232H FDA UDI
- Primary DI / UDI-DI
- 10817522010236 FDA UDI
- 510(k) Number
- K960080 FDA UDI
- FDA Product Code
- FMT FDA UDI
- GMDN Term
- Environmental sensor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5130 FDA UDI
- 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
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
No
FDA UDI
Category: Environmental sensor
AccuTemp Probe by Kentec Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Environmental sensor.
- Ameritus — KENTEC MEDICAL, INC. · Class II
- Ameritus — KENTEC MEDICAL, INC. · Class II
- Ameritus — KENTEC MEDICAL, INC. · Class II
- AccuTemp Probe — KENTEC MEDICAL, INC. · Class II
- AccuTemp Probe — KENTEC MEDICAL, INC. · Class II
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
- Kentec Medical, Inc.
Sources (1)
- FDA UDI 7a37fbe4-629e-4acf-826a-60049b6cbdcf 36 fields · synced Jun 8, 2026