Identity
- Trade Name
- Inspire FDA UDI
- Generic Name
- Implantable sleep apnoea treatment system, respiration-sensing FDA UDI
- Device Name
- The Model 2740S SleepSync Programmer Application is a standalone software that is downloaded and installed on a user-owned computer and paired by the user (clinician) with the Model 2740C Programmer Cable to non-invasively interrogate and program the Implantable Pulse Generator (IPG) of the Inspire Upper Airway Stimulation (UAS) System. The SleepSync Programmer Application provides the graphic user interface (GUI) for the SleepSync Programmer System (Model 2740S and Model 2740C) while the Programmer Cable provides the communications interface between the SleepSync Programmer Application and the IPG. The SleepSync Programmer Application has the capability to monitor respiratory waveforms, program stimulation modes, adjust stimulation parameter values, and store waveforms and settings. FDA UDI
- Model / Reference
- 900-029-001 FDA UDI
- Description
- The Model 2740S SleepSync Programmer Application is a standalone software that is downloaded and installed on a user-owned computer and paired by the user (clinician) with the Model 2740C Programmer Cable to non-invasively interrogate and program the Implantable Pulse Generator (IPG) of the Inspire Upper Airway Stimulation (UAS) System. The SleepSync Programmer Application provides the graphic user interface (GUI) for the SleepSync Programmer System (Model 2740S and Model 2740C) while the Programmer Cable provides the communications interface between the SleepSync Programmer Application and the IPG. The SleepSync Programmer Application has the capability to monitor respiratory waveforms, program stimulation modes, adjust stimulation parameter values, and store waveforms and settings. FDA UDI
Identifiers
- Catalog Number
- 2740S FDA UDI
- Primary DI / UDI-DI
- 00810098650038 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
- 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: Implantable sleep apnoea treatment system, respiration-sensing
Inspire by Inspire Medical Systems — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Implantable sleep apnoea treatment system, respiration-sensing.
- Inspire — Inspire Medical Systems · Class III
- Inspire — Inspire Medical Systems · Class III
- Inspire — Inspire Medical Systems · Class III
- Inspire — Inspire Medical Systems · Class III
- Inspire — Inspire Medical Systems · Class III
- Inspire — Inspire Medical Systems · Class III
- Inspire — Inspire Medical Systems · Class III
- Inspire — Inspire Medical Systems · Class III
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 78c2f1da-8751-4ed8-bc0e-716813949fe3 35 fields · synced May 30, 2026