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Gentlecath

FDA UDI

Class II (US FDA UDI)

by Convatec, Purchasing Department

Identity

Trade Name
GENTLECATH FDA UDI
Generic Name
Indwelling urethral drainage balloon catheter, non-antimicrobial FDA UDI
Device Name
CVT GENTLECATH CLOSED TMNN CH14 KIT FDA UDI
Model / Reference
421421 FDA UDI
Description
CVT GENTLECATH CLOSED TMNN CH14 KIT FDA UDI

Identifiers

Catalog Number
421421 FDA UDI
Primary DI / UDI-DI
04026704582372 FDA UDI
510(k) Number
K010420 FDA UDI
FDA Product Code
FCM FDA UDI
KOD FDA UDI
GMDN Term
Indwelling urethral drainage balloon catheter, non-antimicrobial FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5130 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Gentlecath by Convatec, Purchasing Department — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K010420 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Convatec, Purchasing Department

Sources (1)

  • FDA UDI 9a803e9b-a6dc-4904-8e26-4e129a93187c 38 fields · synced May 31, 2026