Identity
- Trade Name
- BD Ready-to-Use Hydrophilic Catheter EUDAMEDBD Intermittent FDA UDI
- Generic Name
- Single-administration urethral drainage catheter FDA UDI
- Device Name
- Ready-to-Use Hydrophilic Catheter EUDAMEDBD Ready-To-Use Hydrophilic Catheter FDA UDI
- Model / Reference
- RTU10F EUDAMEDFDA UDI
- Description
- BD Ready-To-Use Hydrophilic Catheter FDA UDI
Identifiers
- Catalog Number
- RTU10F FDA UDI
- Primary DI / UDI-DI
- 06948796204049 EUDAMEDFDA UDI
- Basic UDI-DI
- 69487962NC0003Q8 EUDAMED
- 510(k) Number
- K192468 FDA UDI
- FDA Product Code
- GBM FDA UDIEZD FDA UDI
- EMDN Code
- U01010501 NELATON CATHETERS, 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 — 10 French FDA UDICatheter Length — 7.5 Inch FDA UDI
BD Ready-to-Use Hydrophilic Catheter by Hangzhou Bever Medical Devices Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 69487962NC0003Q8 | 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 ac78d935-e99a-42d9-8296-08a29918f527 61 fields · synced Jun 19, 2026
- FDA UDI 9a4844f0-9b32-4071-92de-4bcc0ed52f17 37 fields · synced May 30, 2026
- EUDAMED 66928193-89d0-4667-80fa-e29480bcb55c 61 fields · synced Jun 19, 2026