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Kohli Catheter

FDA UDI

Class II (US FDA UDI)

by Nellie Medical, LLC

Identity

Trade Name
Kohli Catheter FDA UDI
Generic Name
Indwelling urethral drainage balloon catheter, non-antimicrobial FDA UDI
Device Name
Kohli Urinary Drainage Catheter, 16 Fr, Silicone FDA UDI
Model / Reference
20-100 FDA UDI
Description
Kohli Urinary Drainage Catheter, 16 Fr, Silicone FDA UDI

Identifiers

Catalog Number
20-100 FDA UDI
Primary DI / UDI-DI
00860239001304 FDA UDI
510(k) Number
K172422 FDA UDI
FDA Product Code
EZL 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
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

Dimensions & Sizes

Size
Catheter Length — 440 Millimeter FDA UDI
Catheter Gauge — 16 French FDA UDI

Category: Indwelling urethral drainage balloon catheter, non-antimicrobial

Kohli Catheter by Nellie Medical, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Indwelling urethral drainage balloon catheter, non-antimicrobial.

Cleared under the same submission

K172422 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nellie Medical, LLC

Sources (1)

  • FDA UDI f348ea0e-aff5-4701-91b4-9cc0d03e93b4 37 fields · synced May 30, 2026