FlexTip Plus Epidural Catheterization Kit
by Arrow International LLC (Subsidiary of Teleflex Incorporated) 5 variants
Ref UR-05501-FR1, DE-05501-LE, ALZANO-05400-B, BE-05400-DCSHO, DE-05501-LHE, FR-05501-10A, IT-05400-DC, FR-05501-12A, FR-05501-09DC, FR-05501-04, TI-05501-ME, DE-05501-LKSCH, AT-05501-LEO1
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number08019020000000000000120K3 | Date2 Apr 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Trade Name
- FlexTip Plus Epidural Catheterization KitFlexTip Plus Epidural Catheterization Kit, Multi-Port Catheter
- Device Name
- Anesthesia Procedure Packs - Catheters
- Model / Reference
- UR-05501-FR1, DE-05501-LE, ALZANO-05400-B, BE-05400-DCSHO, DE-05501-LHE, FR-05501-10A, IT-05400-DC, FR-05501-12A, FR-05501-09DC, FR-05501-04, TI-05501-ME, DE-05501-LKSCH, AT-05501-LEO1
- Primary DI / UDI-DI
- 30801902196140, 10801902212877, 30801902195945, 10801902195965, 10801902200256, 10801902212822, 10801902196030, 10801902212839, 10801902197549, 30801902196003, 10801902197662, 10801902197686, 10801902212853
- Basic UDI-DI
- 08019020000000000000120K3
- EMDN Code
- N02010199 Peridural / epidural spinal catheters and kits - other
- Device Class
- Class IIb
- Medical Purpose
- The procedure packs contain CE-marked medical devices, which are packaged together and shipped to a customer upon request for physician/medical professional use. The devices can be used together or used individually. Epidural catheter permits access to the epidural space for the administration of epidural anaesthetic
Manufacturer details
- EUDAMED SRN
- US-PR-000023158
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