Inspire
Basic Information
- Brand Name
- Inspire
- Primary DI
- 00855728005550
- Version / Model
- 900-004-073
- Catalog Number
- 2740
- Company Name
- Inspire Medical Systems, Inc.
- Labeler DUNS
- 012419779
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-11-11
- Public Version
- 3
- Public Version Date
- 2020-10-16
- Public Version Status
- Update
- Public Device Record Key
- 2de56548-4edb-4b9e-adc4-622089556365
Device 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.
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 |
|---|---|---|---|---|
| 34210 | Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system | An assembly of battery-powered devices intended to apply periodic electrical stimuli to the vagus nerve to help control seizures and/or to help treat psychiatric disorder symptoms (e.g., depression). The vagus nerve stimulation (VNS) is provided through an implantable pulse generator, typically placed in the anterior chest wall, and leads that run subcutaneously to where their electrodes are implanted around the left vagus nerve. The system may be programmed externally following implantation. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00855728005550 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P130008 | 034 |