Identity
- Trade Name
- BD Intermittent Catheter EUDAMEDBD Intermittent FDA UDI
- Generic Name
- Single-administration urethral drainage catheter FDA UDI
- Device Name
- Intermittent Catheter EUDAMEDBD Intermittent Catheter FDA UDI
- Model / Reference
- BUC12F EUDAMEDFDA UDI
- Description
- BD Intermittent Catheter FDA UDI
Identifiers
- Catalog Number
- BUC12F FDA UDI
- Primary DI / UDI-DI
- 06948796203936 EUDAMEDFDA UDI
- Basic UDI-DI
- 69487962NC0001Q4 EUDAMED
- 510(k) Number
- K111405 FDA UDI
- FDA Product Code
- GBM FDA UDI
- EMDN Code
- U01010502 NELATON CATHETERS, NON SELF-LUBRICATING EUDAMED
- GMDN Term
- Single-administration urethral drainage catheter FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5130 FDA UDI
- Market of Registration
- Poland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 12 French FDA UDICatheter Length — 6.3 Inch FDA UDI
BD Intermittent Catheter by Hangzhou Bever Medical Devices Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69487962NC0001Q4 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Hangzhou Bever Medical Devices Co., Ltd.
- EUDAMED SRN
- CN-MF-000018408
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (3)
- EUDAMED 96eb0b03-51b2-45f4-86a9-844d023cb8fc 61 fields · synced Jun 19, 2026
- FDA UDI 88617573-e839-4d6c-851b-ecc1b95f6612 37 fields · synced May 30, 2026
- EUDAMED 0d3705e7-d2fc-4d4a-9d1e-45bf891f2620 61 fields · synced Jun 14, 2026