KANGAROO OMNI Non-sterile Enteral Feeding Pump Sets-2a
Ref BSPFDModel KANGAROO OMNI Non-sterile Enteral Feeding Pump Sets-2a
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 | Number063014000000000000005066R 10192253068900 | Date22 Sep 2026 | StatusActive |
| United States | GUDID listing GUDID | Number10192253068900 | Date4 Aug 2023 | 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- Withdrawn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
- Trade Name
- Kangaroo
- Generic Name
- Enteral feeding pump
- Device Name
- KANGAROO OMNI Non-sterile Enteral Feeding Pump Sets-2a
- Model / Ref / Catalog
- KANGAROO OMNI Non-sterile Enteral Feeding Pump Sets-2a, BSPFD
- Primary DI / UDI-DI
- 10192253068900, 10885380177149
- Basic UDI-DI
- 063014000000000000005066R
- FDA Product Code
- LZH
- EMDN Code
- A080101 Enteral feeding bags and containers (including those via pump), single-use
- GMDN Term
- Enteral feeding pump
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 880.5725
- EU market of registration
- Ireland
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIa | Class II |
Manufacturer details
- EUDAMED SRN
- US-MF-000006765
- Authorised representative
- Cardinal Health Ireland Manufacturing Limited IE-AR-000001988
Other devices from Cardinal Health 200, LLC
Properties
Other properties (18)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No