Identity
- Trade Name
- USB 2.0 Cable (WireFree) FDA UDI
- Generic Name
- Medical device USB cable FDA UDI
- Device Name
- 6 ft. USB 2.0 cable for connecting a PhysioMonitor, SoloVision or VisionPort to a computer FDA UDI
- Model / Reference
- PB-200 FDA UDI
- Description
- 6 ft. USB 2.0 cable for connecting a PhysioMonitor, SoloVision or VisionPort to a computer FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00853818007187 FDA UDI
- 510(k) Number
- K123399 FDA UDI
- FDA Product Code
- IKN FDA UDIHCC FDA UDIHCS FDA UDIKQX FDA UDI
- GMDN Term
- Medical device USB cable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.1375 FDA UDI882.5050 FDA UDI882.1570 FDA UDI888.1500 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
Yes
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Medical device USB cable
USB 2.0 Cable (WireFree) by Precision Biometrics Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K123399 also covers:
- DynaVision Belts — PRECISION BIOMETRICS INC
- DynaVision Dynamic sEMG Electrodes — PRECISION BIOMETRICS INC
- Dynamic Lead Wire Set — PRECISION BIOMETRICS INC
- Flexlite Charging Cable — PRECISION BIOMETRICS INC
- MyoPad Vault — PRECISION BIOMETRICS INC
- MyoVision DynaVision Dynamic sEMG — PRECISION BIOMETRICS INC
- MyoVision FlexVision Inclinometers — PRECISION BIOMETRICS INC
- MyoVision PhysioMonitor Hub — PRECISION BIOMETRICS INC
- MyoVision ScanVision Static sEMG Scanners — PRECISION BIOMETRICS INC
- MyoVision Software — PRECISION BIOMETRICS INC
- MyoVision Software — PRECISION BIOMETRICS INC
- MyoVision Software — PRECISION BIOMETRICS INC
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
- Precision Biometrics Inc
Sources (1)
- FDA UDI e642d6a7-57b1-4664-9355-f7a5c7278886 34 fields · synced May 30, 2026