Identity
- Trade Name
- Conveen Contour FDA UDI
- Generic Name
- Wearable adult urine collection bag, open-ended FDA UDI
- Device Name
- Urine collection bag. Sterile. Leg bag. Inlet tube: 18 inch (45 cm). 21 oz. FDA UDI
- Model / Reference
- 05171 FDA UDI
- Description
- Urine collection bag. Sterile. Leg bag. Inlet tube: 18 inch (45 cm). 21 oz. FDA UDI
Identifiers
- Catalog Number
- 05171 FDA UDI
- Primary DI / UDI-DI
- 05708932702966 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
MR Safe FDA UDI
Dimensions & Sizes
- Size
- Length — 45 Centimeter FDA UDITotal Volume — 600 Milliliter FDA UDILength — 18 Inch FDA UDITotal Volume — 21 Fluid Ounce FDA UDI
Category: Wearable adult urine collection bag, open-ended
Conveen Contour by Coloplast A/S — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Wearable adult urine collection bag, open-ended.
- SteriGear — Sterigear, LLC · Class II
- Urine Bag — Well Lead Medical Co., Ltd · Class II
- Urine Bag — Well Lead Medical Co., Ltd · Class II
- Flexicare — FLEXICARE MEDICAL LIMITED · Class I
- Urine Bag — Well Lead Medical Co., Ltd · Class II
- Flexicare — FLEXICARE MEDICAL LIMITED · Class I
- Leg Bag — C. R. Bard, Inc. · Class I
- Uro-Safe® Disposable Vinyl Leg Bag 18 oz. (550 mL.) — UROCARE PRODUCTS, INC. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Coloplast A/S
Sources (2)
- FDA UDI bf6ea335-1c9f-4b65-b711-b1fcf7f597d5 36 fields · synced Oct 7, 2026
- EUDAMED 1 fields · synced Jun 18, 2026