J-Vac
Ref 2160Model Reservoirs
Active
CE MDR
Valid until
Not listed
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number0705031a020524J 10705031003293 | Date14 Jan 2026 | StatusActive |
| United States | GUDID listing GUDID | Number10705031003293 | Date23 Sep 2015 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Generic Name
- Closed-wound/centesis drainage receptacle
- Device Name
- J-VAC Closed Wound Drainage Products and Accessories (Including BLAKE Drains)
- Model / Ref / Catalog
- Reservoirs, 2160
- Primary DI / UDI-DI
- 10705031003293
- Basic UDI-DI
- 0705031a020524J
- FDA Product Code
- JOL
- EMDN Code
- A0601010102 Drainage systems with reservoir
- GMDN Term
- Closed-wound/centesis drainage receptacle
- Device Class
- Class I EUDAMEDClass II GUDID
- Regulation Number
- 880.6740
- EU market of registration
- Belgium
- GUDID distribution status
- In Commercial Distribution
- MRI Safety
- MR Unsafe
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class I | Class II |
| Contains Latex | No | Yes |
Manufacturer details
- EUDAMED SRN
- US-MF-000013113
- Authorised representative
- Johnson & Johnson Medical GmbH DE-AR-000007712
Other devices from Ethicon Inc.
Properties
Other properties (16)
- Implantable: No
- Reusable: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Serial Number: No
- Manufacturing Date: No