Identity
- Trade Name
- NeuRx DPS™ Clinical Station Kit, HDE FDA UDI
- Generic Name
- Intramuscular diaphragm/phrenic nerve electrical stimulation system programmer FDA UDI
- Model / Reference
- 20-0037 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00852184003205 FDA UDI
- FDA Product Code
- OIR FDA UDI
- GMDN Term
- Intramuscular diaphragm/phrenic nerve electrical stimulation system programmer 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
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Intramuscular diaphragm/phrenic nerve electrical stimulation system programmer
NeuRx DPS™ Clinical Station Kit, HDE by Synapse Biomedical, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Intramuscular diaphragm/phrenic nerve electrical stimulation system programmer.
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Manufacturer's product page: NeuRx DPS®
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 1f348548-1739-49d0-8ba3-7fa6ced755bc 32 fields · synced May 30, 2026