Identity
- Trade Name
- Unimed FDA UDI
- Generic Name
- General-purpose patient temperature probe, single-use FDA UDI
- Device Name
- Disposable Thermometer Probe/Drager/Pediatri/Skin/Injection molding straight groove/1.5M FDA UDI
- Model / Reference
- TDG15-DPS FDA UDI
- Description
- Disposable Thermometer Probe/Drager/Pediatri/Skin/Injection molding straight groove/1.5M FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06945664858786 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
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
Yes
FDA UDI
Category: General-purpose patient temperature probe, single-use
A temperature sensing device intended to be placed into a body orifice or on the body surface, and used in conjunction with a separate parent device with a display (e.g., electronic patient thermometer, infant warmer) to enable measurement/monitoring of a patient’s temperature.
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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
- Unimed Medical Supplies, Inc.
Sources (1)
- FDA UDI 9d51adf1-2c7a-43ab-a887-e19e4d2110a4 33 fields · synced Jun 22, 2026