Administrations Sets With Neuraxial Connectors
General Hospital · 21 CFR 880.5440
The connector for neuraxial applications is intended to facilitate ANSI/AAMI/ISO 80369-6:2016 compliant neuraxial specific connections.
Recent MDR events
53 adverse event reports on file
- NRFIT ADMINISTRATION SETMay 14, 2025MalfunctionSmiths Healthcare Manufacturing S.a. De C.v.3012307300-2025-05673
- NRFIT EXTENSION SET W/ FILTERApr 17, 2025MalfunctionIcu Medical, Inc., Minneapolis, Mn3012307300-2025-04404
- NRFIT EXTENSION SET W/ FILTERApr 17, 2025MalfunctionSmiths Healthcare Manufacturing S.a. De C.v.3012307300-2025-04514
- NRFIT ADMINISTRATION SETMar 19, 2025MalfunctionSmiths Healthcare Manufacturing S.a. De C.v.9617604-2025-00198
- CADD EXTENSION SETMar 17, 2025MalfunctionSmiths Healthcare Manufacturing S.a. De C.v.3012307300-2025-02998
- NRFIT, CASSETTE RESERVOIR 250MLMar 11, 2025MalfunctionSmiths Healthcare Manufacturing S.a. De C.v.3012307300-2025-02712
- CASSETTE RESERVOIRFeb 27, 2025MalfunctionSmiths Healthcare Manufacturing S.a. De C.v.3012307300-2025-02294
- NRFIT EXTENSION SET W/ FILTERFeb 10, 2025MalfunctionSmiths Healthcare Manufacturing S.a. De C.v.9617604-2025-00118
- CADD CASSETTE RESERVOIRS - FLOW STOPDec 16, 2024MalfunctionSmiths Healthcare Manufacturing S.a. De C.v.9617604-2024-00942
- CADD CASSETTE RESERVOIRDec 6, 2024MalfunctionSmiths Healthcare Manufacturing S.a. De C.v.3012307300-2024-14589
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
8 firms currently registered for this product code
Baxter Healthcare, S.a.
Haina San Cristobal, DO
Baxter Healthcare Corporation
ROUND LAKE, IL, US
Icu Medical, Inc.
DUBLIN, OH, US
Icu Medical Healthcare Manufacturing S.a. De C.v.
Tijuana, B.C. C.P. Baja California, MX
Icu Medical Healthcare Manufacturing S.a. De C.v.
APODACA Nuevo Leon, MX
Isomedix Operations Inc.
SAN DIEGO, CA, US
Sterigenics Belgium Petit Rechain S.a.
Verviers Liege, BE
Icu Medical, Inc.
SAN CLEMENTE, CA, US
510(k) clearances
4 clearances for this product code
- Care FusionJul 21, 2023
K221319 · BD Alaris Pump Epidural Infusion Set
- Baxter Healthcare CorporationNov 23, 2021
K211649 · PCEA Syringe Set
- Smiths Medical Asd, Inc.May 17, 2018
K172592 · CADD Yellow High Volume Administration Set with NRFit connector
- Smiths Medical Asd, Inc.Jul 20, 2017
K162219 · CADD® Infusion Disposables Portfolio with NRFit connectors