FDA UDI
In Commercial Distribution
🇺🇸 United States
Inspire
DI: 00855728005000
·
Model: 900-002-005
·
Inspire Medical Systems, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Inspire
- Primary DI
- 00855728005000
- Version / Model
- 900-002-005
- Catalog Number
- 4323
- Company Name
- Inspire Medical Systems, Inc.
- Labeler DUNS
- 012419779
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-24
- Public Version
- 5
- Public Version Date
- 2020-10-16
- Public Version Status
- Update
- Public Device Record Key
- 84457d60-e752-4e1b-90d5-8a326e9190e5
Device Description
The sensing lead incorporates a differential pressure sensor that detects respiratory cycles. The connector end of the lead is connected to the IPG. The sensor is implanted in between the intercostal muscle layers. The device senses relative pressure variations that correspond to the respiration cycle. The pressure waveform is monitored by the IPG and triggers stimulation therapy synchronous with inspiration.
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 Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| 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 | 00855728005000 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P130008 | 001 |