Identity
- Trade Name
- Inspire FDA UDI
- Generic Name
- Implantable sleep apnoea treatment system, respiration-sensing FDA UDI
- Device Name
- The Inspire® Stimulation Lead (Model 4063) is designed to deliver stimulation to the hypoglossal nerve for the treatment of obstructive sleep apnea. The lead features a flexible, self-sizing cuff. Electrodes in the inner surface of the cuff deliver stimulation to the nerve. The lead incorporates a standard connector for coupling to the Inspire implantable pulse generator (IPG). FDA UDI
- Model / Reference
- 900-013-001 FDA UDI
- Description
- The Inspire® Stimulation Lead (Model 4063) is designed to deliver stimulation to the hypoglossal nerve for the treatment of obstructive sleep apnea. The lead features a flexible, self-sizing cuff. Electrodes in the inner surface of the cuff deliver stimulation to the nerve. The lead incorporates a standard connector for coupling to the Inspire implantable pulse generator (IPG). FDA UDI
Identifiers
- Catalog Number
- 4340 FDA UDI
- Primary DI / UDI-DI
- 00855728005796 FDA UDI
- PMA Number
- P130008 FDA UDI
- FDA Product Code
- MNQ FDA UDI
- GMDN Term
- Implantable sleep apnoea treatment system, respiration-sensing FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Inspire by Inspire Medical Systems — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
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Manufacturer
- Manufacturer
- Inspire Medical Systems
Sources (1)
- FDA UDI ff0412a9-52d1-4726-b852-4dd4cb910fb4 36 fields · synced Jun 1, 2026