SnapLock(TM) Catheter/Syringe Adapter with NRFit(R) connector
by Arrow International LLC (Subsidiary of Teleflex Incorporated)
Ref SL19N
Active
Valid until
Not listed
FDA recalls
1 ongoingDocuments
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number08019020000000000000158KU 10801902195866 | Date19 May 2026 | StatusActive |
| United States | GUDID listing GUDID | Number10801902195866 | Date19 Nov 2025 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Recalls
-
- Ongoing Z-2364-2026
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
-
- Terminated Z-1179-2020
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
-
- Terminated Z-1962-2018
Product sterility may be compromised due to unsealed packaging.
-
- Terminated Z-2462-2015
the catheter peel-away component hub tabs may prematurely detach. One injury reported.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- SnapLock(TM) Catheter/Syringe Adapter with NRFit(R) connector EUDAMEDArrow GUDID
- Generic Name
- Epidural anaesthesia set, medicated
- Device Name
- SnapLock Adapter
- Model / Ref / Catalog
- SL19N, IPN920596
- Primary DI / UDI-DI
- 10801902195866
- Basic UDI-DI
- 08019020000000000000158KU
- 510(k) Number
- FDA Product Code
- CAZ
- EMDN Code
- A070103 Infusion tubing adapters and connectors
- GMDN Term
- Epidural anaesthesia set, medicated
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 868.5140
- EU market of registration
- Ireland
- GUDID distribution status
- In Commercial Distribution
- MRI Safety
- MR Safe
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | SL19N | IPN920596 |
| Device Class | Class IIa | Class II |
Manufacturer details
- EUDAMED SRN
- US-MF-000024256
- Authorised representative
- Teleflex Medical IE-AR-000015869
Other devices from Arrow International LLC (Subsidiary of Teleflex Incorporated)
See all devices from Arrow International LLC (Subsidiary of Teleflex Incorporated) →
Properties
Other properties (17)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No