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UR-Assure

FDA UDI

Class I (US FDA UDI)

by Precision Dynamics Corporation

Identity

Trade Name
UR-Assure FDA UDI
Generic Name
Adhesive paediatric urine collection bag, open-ended FDA UDI
Device Name
Pediatric Urine Collectors, Sterile, 160MIL FDA UDI
Model / Reference
05002-00-MCF FDA UDI
Description
Pediatric Urine Collectors, Sterile, 160MIL FDA UDI

Identifiers

Primary DI / UDI-DI
10687225301852 FDA UDI
FDA Product Code
EXI FDA UDI
GMDN Term
Adhesive paediatric urine collection bag, open-ended FDA UDI

Classification

Device Class
Class I 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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Adhesive paediatric urine collection bag, open-ended

UR-Assure by Precision Dynamics Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Adhesive paediatric urine collection bag, open-ended.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Precision Dynamics Corporation

Sources (1)

  • FDA UDI dee6a01a-7f56-4ff0-9975-5b49b0515def 33 fields · synced May 30, 2026