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Foley Catheter 2-Way

FDA UDI

Class II (US FDA UDI)

by Fuji Systems Corp.

Identity

Trade Name
FOLEY CATHETER 2-WAY FDA UDI
Generic Name
Indwelling urethral drainage balloon catheter, non-antimicrobial FDA UDI
Device Name
Foley Catheter is applied to a dysuria, uroschesis patient for urine drainage from bladder. FDA UDI
Model / Reference
FR.6 - 1.5ML FDA UDI
Description
Foley Catheter is applied to a dysuria, uroschesis patient for urine drainage from bladder. FDA UDI

Identifiers

Catalog Number
1210106 FDA UDI
Primary DI / UDI-DI
04544050056243 FDA UDI
510(k) Number
K894883 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

No

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

No

FDA UDI

Category: Indwelling urethral drainage balloon catheter, non-antimicrobial

Foley Catheter 2-Way by Fuji Systems Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Fuji Systems Corp.

Sources (1)

  • FDA UDI a219d6aa-7684-492e-aca9-7fe8832e709a 35 fields · synced Jun 1, 2026