Identity
- Trade Name
- SENSIMED Triggerfish® Data Cable FDA UDI
- Generic Name
- Ambulatory monitoring/recording system transceiver/cable FDA UDI
- Device Name
- An electrical cable with connector that connects the SENSIMED Triggerfish® Recorder device with SENSIMED Triggerfish® eye patch antenna, used to transmit electrical power and data in between FDA UDI
- Model / Reference
- DC.V.5.1 FDA UDI
- Description
- An electrical cable with connector that connects the SENSIMED Triggerfish® Recorder device with SENSIMED Triggerfish® eye patch antenna, used to transmit electrical power and data in between FDA UDI
Identifiers
- Catalog Number
- ST5010 FDA UDI
- Primary DI / UDI-DI
- 07640153470140 FDA UDI
- 510(k) Number
- DEN140017 FDA UDI
- FDA Product Code
- PLZ FDA UDI
- GMDN Term
- Ambulatory monitoring/recording system transceiver/cable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.1925 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Ambulatory monitoring/recording system transceiver/cable
SENSIMED Triggerfish® Data Cable by Sensimed AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ambulatory monitoring/recording system transceiver/cable.
- ActiGraph — ActiGraph L.L.C. · Class I
- Bedside Mobility Monitor — ATLAS LIFT TECH, INC. · Class I
- LEAF™ — Smith & Nephew Medical, Ltd. · Class I
- LEAF™ — Smith & Nephew Medical, Ltd. · Class I
- LEAF™ — Smith & Nephew Medical, Ltd. · Class I
- AURA — Branchpoint & Aura Development LLC · Class II
Cleared under the same submission
DEN140017 also covers:
- SENSIMED Triggerfish® Antenna LEFT — Sensimed AG
- SENSIMED Triggerfish® Antenna LEFT — Sensimed AG
- SENSIMED Triggerfish® Antenna RIGHT — Sensimed AG
- SENSIMED Triggerfish® Antenna RIGHT — Sensimed AG
- SENSIMED Triggerfish® Recorder — Sensimed AG
- SENSIMED Triggerfish® Recorder Sleeve — Sensimed AG
- SENSIMED Triggerfish® Sensor FLAT — Sensimed AG
- SENSIMED Triggerfish® Sensor FLAT — Sensimed AG
- SENSIMED Triggerfish® Sensor MEDIUM — Sensimed AG
- SENSIMED Triggerfish® Sensor MEDIUM — Sensimed AG
- SENSIMED Triggerfish® Sensor SMF — Sensimed AG
- SENSIMED Triggerfish® Sensor STEEP — Sensimed AG
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sensimed AG
Sources (1)
- FDA UDI 66a13886-68c2-4236-a09a-87c946884ad1 37 fields · synced Jun 1, 2026