Identity
- Trade Name
- Truer Medical, Inc. FDA UDI
- Generic Name
- General-purpose patient temperature probe, single-use FDA UDI
- Device Name
- Truer Medical General Purpose Probes are designed for continuous temperature monitoring. Probes can be introduced through oral or rectal openings. Probes tips have special low-friction “frosted” finish to aid in the ease of placement and patient comfort. FDA UDI
- Model / Reference
- GP 14400 FDA UDI
- Description
- Truer Medical General Purpose Probes are designed for continuous temperature monitoring. Probes can be introduced through oral or rectal openings. Probes tips have special low-friction “frosted” finish to aid in the ease of placement and patient comfort. FDA UDI
Identifiers
- Catalog Number
- GP 14400 FDA UDI
- Primary DI / UDI-DI
- 00859290006120 FDA UDI
- 510(k) Number
- K101244 FDA UDI
- FDA Product Code
- FLL FDA UDI
- GMDN Term
- General-purpose patient temperature probe, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.2910 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: General-purpose patient temperature probe, single-use
Truer Medical, Inc. by Truer Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Truer Medical, Inc.
Sources (1)
- FDA UDI e3029b49-8061-42be-b1e5-20b6df590201 36 fields · synced Jun 8, 2026