Identity
- Trade Name
- Conveen Standard EUDAMEDFDA UDI
- Generic Name
- Non-wearable adult urine collection bag, open-ended FDA UDI
- Device Name
- Conveen Standard combi bag non-sterile drainable EUDAMED
- Model / Reference
- 05062 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 05062 FDA UDI
- Primary DI / UDI-DI
- 05708932358064 EUDAMED05708932732420 FDA UDI
- Basic UDI-DI
- 5708932297898A7 EUDAMED
- Unit of Use DI
- 05701780029445 EUDAMED
- FDA Product Code
- NNW FDA UDI
- EMDN Code
- A06030301 URINE COLLECTION BAGS EUDAMED
- GMDN Term
- Non-wearable adult urine collection bag, open-ended FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 876.5250 FDA UDI
- Market of Registration
- Norway EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
- Total Volume — 51 Fluid Ounce FDA UDILength — 36 Inch FDA UDITotal Volume — 1500 Milliliter FDA UDILength — 90 Centimeter FDA UDI
Category: Non-wearable adult urine collection bag, open-ended
Conveen Standard by Coloplast A/S — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Non-wearable adult urine collection bag, open-ended.
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- ASP MEDICAL — Asp Global, LLC · Class I
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 ba14a28f-66e3-4a28-9abd-92cca7babff9 35 fields · synced Jul 11, 2026
- EUDAMED 9ad497b6-94b1-4fe9-95f9-01bfaa5008e4 61 fields · synced Jul 11, 2026