Identity
- Trade Name
- BioRef-DC FDA UDI
- Generic Name
- Intramuscular diaphragm/phrenic nerve electrical stimulation system FDA UDI
- Device Name
- BIOFEEDBACK DEVICE BioRef-DC FDA UDI
- Model / Reference
- FG00019 FDA UDI
- Description
- BIOFEEDBACK DEVICE BioRef-DC FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290017249049 FDA UDI
- FDA Product Code
- FQH FDA UDI
- GMDN Term
- Intramuscular diaphragm/phrenic nerve electrical stimulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5475 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
Yes
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Intramuscular diaphragm/phrenic nerve electrical stimulation system
BioRef-DC by Tavger Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intramuscular diaphragm/phrenic nerve electrical stimulation system.
- System Destination Kit, CE 2 EPG — Synapse Biomedical, Inc. · Class III
- NeuRx DPS™ Surgical Site Start-up Kit — Synapse Biomedical, Inc. · Class III
- Clinician Crimp Tool — Synapse Biomedical, Inc. · Class III
- STERILE Blue Cable Set — Synapse Biomedical, Inc. · Class III
- Connector Holder Kit — Synapse Biomedical, Inc. · Class III
- Clinician Connector Kit — Synapse Biomedical, Inc.
- NeuRx Diaphragm Pacing System — Synapse Biomedical, Inc. · Class III
- NeuRx DPS™ System Kit — Synapse Biomedical, Inc. · Class III
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
- Tavger Ltd
Sources (1)
- FDA UDI 9de65b46-7bb7-42d9-8414-a03794ad21f9 33 fields · synced Jun 8, 2026