Inspire Medical Systems, Inc. 3028 Inspire
Company Name
Inspire Medical Systems, Inc.
Catalog Number
3028
Description
The Model 3028 IPG contains electronics and a battery that are sealed inside a titanium case. The IPG is implanted subcutaneously, below the clavicle in the upper chest, and connect to the stimulation lead and sensing lead. The Model 3028 does not contain any software or firmware. All functions including the telemetry and algorithm have been designed into the hardware of the IPG. The algorithm synchronizes stimulation of the hypoglossal nerve with respiration signals. The IPG processes the same dynamic range of pressure signals (2-48 cmH2O) in order to account for pressure reading variability. Based on typical settings from the STAR pivotal trial, the longevity of the Model 3028’s battery will average 10 years although the device is smaller than the currently approved version (Model 3024). In addition the Model 3028 IPG will allow patients to safely undergo magnetic resonance imaging (MRI) under specified conditions.
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Additional Details
Device Identifier
10810098650141
Is RX
Yes
Is Over the Counter
No
Requires Sterilization
No
Is Sterile
Yes
Is Single Use
Yes
Barcode Mapping
| Unit of Measurement | Eaches | GTIN |
|---|---|---|
| Each | 1 | 10810098650141 |