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Urinary Leg Bag

FDA UDI

Class II (US FDA UDI)

by Dynarex Corp.

Identity

Trade Name
Urinary Leg Bag FDA UDI
Generic Name
Wearable adult urine collection bag, open-ended FDA UDI
Device Name
Urinary Leg Bag, Medium, 600mL, with Anti-Reflux Valve, Sterile Fluid Pathway FDA UDI
Model / Reference
4281 FDA UDI
Description
Urinary Leg Bag, Medium, 600mL, with Anti-Reflux Valve, Sterile Fluid Pathway FDA UDI

Identifiers

Primary DI / UDI-DI
00616784428116 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

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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Wearable adult urine collection bag, open-ended

Urinary Leg Bag 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 2ea1efd6-0e03-4e7a-92b5-a8a95135d8de 33 fields · synced May 30, 2026