Identity
- Trade Name
- BRAUN FDA UDI
- Generic Name
- Electronic thermometer probe cover FDA UDI
- Device Name
- Braun ThermoScan PC20 Probe Covers, for use with PRO6000 series thermometers. This package contains 20 probe covers. Not for individual sale. The probe cover is intended for use as a sanitary barrier between the thermometer and ear canal. FDA UDI
- Model / Reference
- PC20RFMNV1 FDA UDI
- Description
- Braun ThermoScan PC20 Probe Covers, for use with PRO6000 series thermometers. This package contains 20 probe covers. Not for individual sale. The probe cover is intended for use as a sanitary barrier between the thermometer and ear canal. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00328785000368 FDA UDI
- FDA Product Code
- FLL FDA UDI
- GMDN Term
- Electronic thermometer probe cover 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
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: Electronic thermometer probe cover
Braun by Kaz Usa, 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
- Kaz Usa, Inc.
Sources (1)
- FDA UDI afb96d1a-c8da-465a-843b-4a201cdd667e 34 fields · synced Jun 1, 2026