Identity
- Trade Name
- TwitchView™ FDA UDI
- Generic Name
- Electrical-only medical device connection cable, reusable FDA UDI
- Device Name
- A reusable electrical cable that connects the TwitchView™ monitor to the single-use electrode array. FDA UDI
- Model / Reference
- Cable Assembly v1 FDA UDI
- Description
- A reusable electrical cable that connects the TwitchView™ monitor to the single-use electrode array. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860298001079 FDA UDI
- 510(k) Number
- K172843 FDA UDI
- FDA Product Code
- KOI FDA UDI
- GMDN Term
- Electrical-only medical device connection cable, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.2775 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
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electrical-only medical device connection cable, reusable
TwitchView™ by Blink Device Company — 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
- Blink Device Company
Sources (1)
- FDA UDI eb29afaf-0170-463d-b915-76574f3c565e 34 fields · synced Jun 9, 2026