Identity
- Trade Name
- Oral Temp Digital Thermometer FDA UDI
- Generic Name
- Intermittent electronic patient thermometer FDA UDI
- Device Name
- Features: ~ Flexible tip for convenient use ~ Accurate to ±0.1 °C / ±0.2 °F ~ Waterproof ~ Large easy-to-read LCD ~ Last memory recall ~ Fever alarm ~ Low battery indicator ~ Automatic shut-off ~ For oral, rectal, or axillary use FDA UDI
- Model / Reference
- MT4035 FDA UDI
- Description
- Features: ~ Flexible tip for convenient use ~ Accurate to ±0.1 °C / ±0.2 °F ~ Waterproof ~ Large easy-to-read LCD ~ Last memory recall ~ Fever alarm ~ Low battery indicator ~ Automatic shut-off ~ For oral, rectal, or axillary use FDA UDI
Identifiers
- Catalog Number
- 1546 FDA UDI
- Primary DI / UDI-DI
- 00891237001546 FDA UDI
- FDA Product Code
- FLL FDA UDI
- GMDN Term
- Intermittent electronic patient thermometer 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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: Intermittent electronic patient thermometer
Oral Temp Digital Thermometer by Home Aide Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Home Aide Diagnostics, Inc.
Sources (1)
- FDA UDI 91926a7a-015f-4051-82a3-ffed464db3a8 36 fields · synced May 30, 2026