Identity
- Trade Name
- System Destination Kit, CE 2 EPG FDA UDI
- Generic Name
- Intramuscular diaphragm/phrenic nerve electrical stimulation system FDA UDI
- Model / Reference
- 20-0063 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00852184003069 FDA UDI
- FDA Product Code
- OIR FDA UDI
- GMDN Term
- Intramuscular diaphragm/phrenic nerve electrical stimulation system FDA UDI
Classification
- Device Class
- Class III 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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Intramuscular diaphragm/phrenic nerve electrical stimulation system
System Destination Kit, CE 2 EPG by Synapse Biomedical, Inc. — Class III — 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 III | Pending data |
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Manufacturer
- Manufacturer
- Synapse Biomedical, Inc.
Sources (1)
- FDA UDI 9408b9db-01cf-42c5-8f6c-8ee0571555b2 32 fields · synced May 31, 2026