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Bag, Urine Collection, Leg, for External Use, Sterile, 20/Cs

FDA UDI

Class II (US FDA UDI)

by Dynarex Corp.

Identity

Trade Name
Bag, Urine Collection, Leg, for External Use, Sterile, 20/Cs FDA UDI
Generic Name
Wearable adult urine collection bag, open-ended FDA UDI
Model / Reference
4290 FDA UDI

Identifiers

Primary DI / UDI-DI
00616784429038 FDA UDI
FDA Product Code
KNX FDA UDI
GMDN Term
Wearable adult urine collection bag, open-ended FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5250 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Wearable adult urine collection bag, open-ended

Bag, Urine Collection, Leg, for External Use, Sterile, 20/Cs by Dynarex Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Wearable adult urine collection bag, open-ended.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dynarex Corp.

Sources (1)

  • FDA UDI 283c4229-293b-44f6-9506-5ca37807dd27 32 fields · synced May 31, 2026