Identity
- Trade Name
- Inspire FDA UDI
- Generic Name
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system FDA UDI
- Device Name
- The sensing lead incorporates a differential pressure sensor that detects respiratory cycles. The connector end of the lead is connected to the IPG. The sensor is implanted in between the intercostal muscle layers. The device senses relative pressure variations that correspond to the respiration cycle. The pressure waveform is monitored by the IPG and triggers stimulation therapy synchronous with inspiration FDA UDI
- Model / Reference
- 900-002-007 FDA UDI
- Description
- The sensing lead incorporates a differential pressure sensor that detects respiratory cycles. The connector end of the lead is connected to the IPG. The sensor is implanted in between the intercostal muscle layers. The device senses relative pressure variations that correspond to the respiration cycle. The pressure waveform is monitored by the IPG and triggers stimulation therapy synchronous with inspiration FDA UDI
Identifiers
- Catalog Number
- 4323 FDA UDI
- Primary DI / UDI-DI
- 10855728005199 FDA UDI
- PMA Number
- P130008 FDA UDI
- FDA Product Code
- MNQ FDA UDI
- GMDN Term
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
Inspire by Inspire Medical Systems — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
P130008 also covers:
- Inspire — Inspire Medical Systems
- Inspire — Inspire Medical Systems
- Inspire — Inspire Medical Systems
- Inspire — Inspire Medical Systems
- Inspire — Inspire Medical Systems
- Inspire — Inspire Medical Systems
- Inspire — Inspire Medical Systems
- Inspire — Inspire Medical Systems
- Inspire — Inspire Medical Systems
- Inspire — Inspire Medical Systems
- Inspire — Inspire Medical Systems
- Inspire — Inspire Medical Systems
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Inspire Medical Systems
Sources (1)
- FDA UDI 1e59eaa7-0431-4ddd-a028-36434bfc36b8 35 fields · synced Jun 7, 2026