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EndoSound® Air Leak Tester

FDA UDI

Class I (US FDA UDI)

by Endosound, Inc.

Identity

Trade Name
EndoSound® Air Leak Tester FDA UDI
Generic Name
Invasive medical device leak tester, mechanical FDA UDI
Device Name
The EndoSound Air Leak Tester is used with a UTM and pressure test cap to test the integrity of the UTM cable. FDA UDI
Model / Reference
5030 FDA UDI
Description
The EndoSound Air Leak Tester is used with a UTM and pressure test cap to test the integrity of the UTM cable. FDA UDI

Identifiers

Catalog Number
5030 FDA UDI
Primary DI / UDI-DI
00850050934110 FDA UDI
FDA Product Code
FCY FDA UDI
GMDN Term
Invasive medical device leak tester, mechanical FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
876.1500 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Invasive medical device leak tester, mechanical

EndoSound® Air Leak Tester by Endosound, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Invasive medical device leak tester, mechanical.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Endosound, Inc.

Sources (1)

  • FDA UDI 699f723b-e2ef-42be-9362-87335e7e2bd6 36 fields · synced May 30, 2026