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Inspire

FDA UDI

Class III (US FDA UDI)

by Inspire Medical Systems

Identity

Trade Name
Inspire FDA UDI
Generic Name
Implantable sleep apnoea treatment system, respiration-sensing FDA UDI
Device Name
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 FDA UDI
Model / Reference
900-009-001 FDA UDI
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 FDA UDI

Identifiers

Catalog Number
4340 FDA UDI
Primary DI / UDI-DI
10855728005458 FDA UDI
PMA Number
P130008 FDA UDI
FDA Product Code
MNQ FDA UDI
GMDN Term
Implantable sleep apnoea treatment system, respiration-sensing FDA UDI

Classification

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

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Implantable sleep apnoea treatment system, respiration-sensing

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

Similar devices

Also classified as Implantable sleep apnoea treatment system, respiration-sensing.

Cleared under the same submission

P130008 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Inspire Medical Systems

Sources (1)

  • FDA UDI bb4a7a7c-5fa6-4bca-97ee-2d64f3ee1274 35 fields · synced Jun 8, 2026