Identity
- Trade Name
- BV Medical FDA UDI
- Generic Name
- Otoscope, direct FDA UDI
- Device Name
- Combo Kit: Royal Blue Fanny Pack: 38-416-344 Sprague Rappaport-Type, Adult, Frosted Blue, Latex Free: 60-870-010 PICCOLIGHT® F.O. Xenon 2.5V Otoscope, Black, Latex Free: 20-207-254-L Classic Aneroid Sphygmomanometer, Royal Blue Nylon Cuff, Adult, Latex: 60-405-250 LED Penlight, Metal, Push Button, Cobalt Blue: 8-380J Fiberglass Tape Measure, BV Logo Sticker, White Case: 80-170-150 Utility scissors 5.5", stainless steel with light blue handle: 80-503-000 Babinski hammer, 8.5" FDA UDI
- Model / Reference
- 20-443-344-OTO-L FDA UDI
- Description
- Combo Kit: Royal Blue Fanny Pack: 38-416-344 Sprague Rappaport-Type, Adult, Frosted Blue, Latex Free: 60-870-010 PICCOLIGHT® F.O. Xenon 2.5V Otoscope, Black, Latex Free: 20-207-254-L Classic Aneroid Sphygmomanometer, Royal Blue Nylon Cuff, Adult, Latex: 60-405-250 LED Penlight, Metal, Push Button, Cobalt Blue: 8-380J Fiberglass Tape Measure, BV Logo Sticker, White Case: 80-170-150 Utility scissors 5.5", stainless steel with light blue handle: 80-503-000 Babinski hammer, 8.5" FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00845821026279 FDA UDI
- FDA Product Code
- DXQ FDA UDILDE FDA UDIERA FDA UDILRW FDA UDIKYT FDA UDIFTY FDA UDIGWZ FDA UDI
- GMDN Term
- Otoscope, direct FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1120 FDA UDI870.1875 FDA UDI874.4770 FDA UDI878.4800 FDA UDI880.6350 FDA UDI882.1700 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
Yes
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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: General-purpose surgical scissors, reusableAneroid manual sphygmomanometerMechanical external stethoscopeOtoscope, direct
BV Medical by Medical, 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
- Medical, Inc.
Sources (1)
- FDA UDI b85ab2ba-06b0-42b0-be3e-e87eeeade855 34 fields · synced May 30, 2026