DEVICE: Inspire (10855728005960)

Device Identifier (DI) Information

Inspire
900-015-001
In Commercial Distribution
3150
Inspire Medical Systems, Inc.
10855728005960
GS1

1
012419779 *Terms of Use
The Model 3150 IPG is the next generation Implantable Pulse Generator (IPG). It contains electronics and a battery that are sealed inside a titanium case. The Model 3150 is smaller in size than the previous model (3028) and eliminates the need of an Inspire respiratory sensing lead by having a built-in sensing accelerometer in the Model 3150 generator itself. The IPG is implanted subcutaneously, below the clavicle in the upper chest, and connects to the Inspire stimulation lead. The Model 3150 introduces improved communication speed between the IPG and the external products along with enhanced security. The Inspire system stimulates the hypoglossal nerve, synchronous with the patient’s respiration cycle using closed loop sensing technology. The timed stimulation elicits a neuromuscular response from the base of the tongue thereby preventing upper airway collapse that causes airflow obstruction in many OSA patients. The Model 3150 IPG will also allow patients to safely undergo magnetic resonance imaging (MRI) under specified conditions.
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Device Characteristics

MR Conditional
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
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.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
MNQ Stimulator, Hypoglossal Nerve, Implanted, Apnea
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P130008 098
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

b8fe624f-ddb9-41bf-a1f9-1740a7eb47e9
December 16, 2024
1
December 06, 2024
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
Yes
Yes
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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