Inspire

FDA UDI

Class III (US FDA UDI)

by Inspire Medical Systems

Identity

Trade Name: Inspire FDA UDI
Generic Name: Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system FDA UDI
Device Name: The patient programmer is an external device that is about the size of a cell phone or PDA, and is used by the patient to activate the Inspire system before they go to sleep. The patient places the programmer over the implanted IPG site, and uses push buttons on top of the programmer to: a.) turn the therapy ON or OFF, b.) temporarily suspend therapy, or c.) make adjustments to the stimulation amplitude (within limits set by the physician). The patient programmer also allows patients to check the status of the IPG battery. There are both visual and audio indicators that provide confirmation of IPG status (Therapy ON/OFF and Battery Status). The patient programmer will only communicate with the Inspire system IPG FDA UDI
Model / Reference: 900-000-016 FDA UDI
Description: The patient programmer is an external device that is about the size of a cell phone or PDA, and is used by the patient to activate the Inspire system before they go to sleep. The patient places the programmer over the implanted IPG site, and uses push buttons on top of the programmer to: a.) turn the therapy ON or OFF, b.) temporarily suspend therapy, or c.) make adjustments to the stimulation amplitude (within limits set by the physician). The patient programmer also allows patients to check the status of the IPG battery. There are both visual and audio indicators that provide confirmation of IPG status (Therapy ON/OFF and Battery Status). The patient programmer will only communicate with the Inspire system IPG FDA UDI

Identifiers

Catalog Number: 3032 FDA UDI
Primary DI / UDI-DI: 00855728005031 FDA UDI
PMA Number: P130008 FDA UDI
FDA Product Code: MNQ FDA UDI
GMDN Term: Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system FDA UDI

Classification

Device Class: Class III FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system

Inspire by Inspire Medical Systems — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

P130008 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class III	Pending data

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Manufacturer

Manufacturer: Inspire Medical Systems

Sources (1)

FDA UDI 531a5ff2-39ce-4715-80b1-ccbf80f0ab11 35 fields · synced Jun 6, 2026

Inspire

Identity

Identifiers

Classification

Clinical & Handling

Similar devices

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

Manufacturer

Sources (1)