Identity
- Trade Name
- Inspire FDA UDI
- Generic Name
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system FDA UDI
- Device Name
- The Model 2740 physician programmer is designed for use by a physician to non invasively interrogate and program the IPG. It is the only component in the Inspire system that contains software. This programmer consists of a tablet computer and a telemetry cable. The telemetry head communicates with the IPG through the skin via short range radio frequency (RF) telemetry, telemetry communication allows the physician to noninvasively interrogate and program the IPG. The telemetry head is powered by a wall outlet connection and wirelessly communicates (via wireless Bluetooth link) with the physician programmer tablet. The physician programmer has the capability to monitor respiratory waveforms, program stimulation modes, adjust stimulation parameter values, and store waveforms and settings. FDA UDI
- Model / Reference
- 900-004-116 FDA UDI
- Description
- The Model 2740 physician programmer is designed for use by a physician to non invasively interrogate and program the IPG. It is the only component in the Inspire system that contains software. This programmer consists of a tablet computer and a telemetry cable. The telemetry head communicates with the IPG through the skin via short range radio frequency (RF) telemetry, telemetry communication allows the physician to noninvasively interrogate and program the IPG. The telemetry head is powered by a wall outlet connection and wirelessly communicates (via wireless Bluetooth link) with the physician programmer tablet. The physician programmer has the capability to monitor respiratory waveforms, program stimulation modes, adjust stimulation parameter values, and store waveforms and settings. FDA UDI
Identifiers
- Catalog Number
- 2740 FDA UDI
- Primary DI / UDI-DI
- 00810098650151 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
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
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
No
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 |
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Manufacturer
- Manufacturer
- Inspire Medical Systems
Sources (1)
- FDA UDI aeb16dba-609f-4e8f-89e1-52576fa77d20 35 fields · synced Jun 1, 2026