FDA UDI
In Commercial Distribution
🇺🇸 United States
Inspire
DI: 00855728005796
·
Model: 900-013-001
·
Inspire Medical Systems, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Inspire
- Primary DI
- 00855728005796
- Version / Model
- 900-013-001
- Catalog Number
- 4340
- Company Name
- Inspire Medical Systems, Inc.
- Labeler DUNS
- 012419779
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-08-16
- Public Version
- 1
- Public Version Date
- 2022-08-24
- Public Version Status
- New
- Public Device Record Key
- ff0412a9-52d1-4726-b852-4dd4cb910fb4
Device 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).
Device Characteristics
- Single Use
- Yes
- 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 Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- 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 | 00855728005796 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P130008 | 074 |