Identity
- Trade Name
- Adtemp™ FDA UDI
- Generic Name
- Intermittent electronic patient thermometer FDA UDI
- Device Name
- ADTEMP I Digital Thermometer,Bulk, no sheaths included FDA UDI
- Model / Reference
- 412-00 FDA UDI
- Description
- ADTEMP I Digital Thermometer,Bulk, no sheaths included FDA UDI
Identifiers
- Catalog Number
- 412-00 FDA UDI
- Primary DI / UDI-DI
- 00634782048549 FDA UDI
- 510(k) Number
- K940686 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
Adtemp™ by American Diagnostic Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K940686 also covers:
- Adtemp™ — American Diagnostic Corporation
- Adtemp™ — American Diagnostic Corporation
- Adtemp™ — American Diagnostic Corporation
- Adtemp™ — American Diagnostic Corporation
- Adtemp™ — American Diagnostic Corporation
- Adtemp™ — American Diagnostic Corporation
- Adtemp™ — American Diagnostic Corporation
- Adtemp™ — American Diagnostic Corporation
- Adtemp™ — American Diagnostic Corporation
- Adtemp™ — American Diagnostic Corporation
- Adtemp™ — American Diagnostic Corporation
- Adtemp™ — American Diagnostic Corporation
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
- American Diagnostic Corporation
Sources (1)
- FDA UDI 2fccc906-671b-4136-807e-860c2f112f10 37 fields · synced May 30, 2026