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Conveen Security+

FDA UDI

Class I (US FDA UDI)

by Coloplast A/S

Identity

Trade Name
Conveen Security+ FDA UDI
Generic Name
Wearable adult urine collection bag, open-ended FDA UDI
Device Name
Conveen Security+. Urine collection bag. Leg bag. Sterile. Inlet tube: 20 inch (50 cm). Incl. 10 x strap set (sterile). 17 oz (500 ml). FDA UDI
Model / Reference
21034 FDA UDI
Description
Conveen Security+. Urine collection bag. Leg bag. Sterile. Inlet tube: 20 inch (50 cm). Incl. 10 x strap set (sterile). 17 oz (500 ml). FDA UDI

Identifiers

Catalog Number
21034 FDA UDI
Primary DI / UDI-DI
05708932539326 FDA UDI
FDA Product Code
FAQ FDA UDI
GMDN Term
Wearable adult 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

Yes

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

No

FDA UDI
MRI Safety
MR Safe FDA UDI

Dimensions & Sizes

Size
Total Volume — 500 Milliliter FDA UDI
Total Volume — 17 Fluid Ounce FDA UDI
Length — 50 Centimeter FDA UDI

Category: Wearable adult urine collection bag, open-ended

Conveen Security+ by Coloplast A/S — Class I — 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
Coloplast A/S

Sources (1)

  • FDA UDI daa77f49-c48f-41e7-8f76-b969f2f61a05 36 fields · synced Jun 1, 2026