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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 Inspire® Respiratory Sensing Lead (Model 4340) is designed to detect respiratory effort. The lead features a pressure sensitive membrane that converts the mechanical energy of respiration into an electrical signal. The lead incorporates a standard connector for coupling to the Inspire implantable pulse generator (IPG) for treatment of obstructive sleep apnea. FDA UDI
Model / Reference
900-014-003 FDA UDI
Description
The Inspire® Respiratory Sensing Lead (Model 4340) is designed to detect respiratory effort. The lead features a pressure sensitive membrane that converts the mechanical energy of respiration into an electrical signal. The lead incorporates a standard connector for coupling to the Inspire implantable pulse generator (IPG) for treatment of obstructive sleep apnea. FDA UDI

Identifiers

Catalog Number
4340 FDA UDI
Primary DI / UDI-DI
00855728005949 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

No

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 9476b069-bb3a-4c01-b163-c30434edb4de 35 fields · synced May 30, 2026