Inspire
Basic Information
- Brand Name
- Inspire
- Primary DI
- 00810098650038
- Version / Model
- 900-029-001
- Catalog Number
- 2740S
- Company Name
- Inspire Medical Systems, Inc.
- Labeler DUNS
- 012419779
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-15
- Public Version
- 1
- Public Version Date
- 2024-05-23
- Public Version Status
- New
- Public Device Record Key
- 78c2f1da-8751-4ed8-bc0e-716813949fe3
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MNQ | Stimulator, Hypoglossal Nerve, Implanted, Apnea | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63433 | Implantable sleep apnoea treatment system, respiration-sensing | An assembly of implantable devices intended for home management of obstructive sleep apnoea (OSA) by improving airway patency through stimulation of the hypoglossal nerve [targeted hypoglossal nerve stimulation (THN)], synchronous with respiration during sleep, to elicit a neuromuscular response at the base of the tongue. It consists primarily of three connected implanted components: a respiratory movement sensor, a pulse generator, and a lead to provide respiration-dependent (and alternatively, fixed-rate) electrical stimulation to the hypoglossal nerve; a patient-operated remote controller/charger and software for device configuration by a healthcare professional are typically included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810098650038 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P130008 | 092 |