Piston Syringe With Neuraxial Connector Epidural, Peripheral, And/or Indirect Cerebral Spinal Fluid Contact
General Hospital · 21 CFR 880.5860
A neuraxial piston syringe is intended to inject or withdraw fluid from the neuraxial space with neuraxial specific connections. This product code may include epidural, peripheral, subarachnoid/spinal block, intrathecal and/or intracerebroventricular administration routes. The connector for neuraxial applications is intended to facilitate ANSI/AAMI/ISO 80369-6:2016 compliant neuraxial specific connections.
Recent MDR events
21 adverse event reports on file
- BD SYRINGE 20ML L/T SSU NRFITDec 4, 2025MalfunctionBd Medical (bd West) Medical Surgical1911916-2025-00777
- BD SYRINGE NRFIT¿ LOKMar 4, 2025MalfunctionBecton Dickinson Medical Systems1213809-2025-00161
- BD SYRINGE NRFIT¿ LOKJan 14, 2025MalfunctionBecton Dickinson Medical Systems1213809-2024-01053
- BD SYRINGE 10ML L/T SSU NRFIT WWSJan 7, 2025MalfunctionBecton Dickinson Medical Systems1213809-2024-01036
- BD SYRINGE NRFIT¿ LOKJan 2, 2025MalfunctionBecton Dickinson Medical Systems1213809-2024-01019
- BD SYRINGE NRFIT¿ LOKDec 26, 2024MalfunctionBecton Dickinson Medical Systems1213809-2024-00996
- SYRINGE 10ML L/T SSU NRFIT WWSDec 22, 2024MalfunctionBecton Dickinson1213809-2024-00986
- SYRINGE 50ML L/T SSU NRFITDec 16, 2024MalfunctionBecton Dickinson1911916-2024-00915
- BD SYRINGE 5ML S/T SSU NRFITNov 24, 2024MalfunctionBecton Dickinson Medical Systems1213809-2024-00877
- BD SYRINGE NRFIT¿ LOKNov 18, 2024MalfunctionBecton Dickinson Medical Systems1213809-2024-00850
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
15 firms currently registered for this product code
B. Braun Medical Ag
ESCHOLZMATT Luzern, CH
Almo-erzeugnisse Erwin Busch Gmbh
BAD AROLSEN Hesse, DE
Becton Dickinson And Company
COLUMBUS, NE, US
Becton, Dickinson And Company
CANAAN, CT, US
International Sterilization Laboratory, Llc
GROVELAND, FL, US
Sterigenics U.s., Llc
Atlanta, GA, US
Jiangsu Caina Medical Co., Ltd
Jiangyin Jiangsu, CN
B. Braun Melsungen Ag
MELSUNGEN Hesse, DE
Artiglass Srl
DUE CARRARE PADOVA, IT
B. Braun Medical Inc.
Allentown, PA, US
Becton Dickinson
FRANKLIN LAKES, NJ, US
Bd Medical
HOLDREGE, NE, US
Rhino Medical Supply Inc
Columbia, SC, US
Intl. Medical Industries
POMPANO BEACH, FL, US
Carefusion 2200, Inc.
Vernon Hills, IL, US
510(k) clearances
5 clearances for this product code
- B.Braun Medical, Inc.Jul 13, 2024
K241385 · Omnifix Syringe NRFit
- Artiglass SrlMay 19, 2022
K213800 · Artiglass NRFitTM Tip L.O.R. Glass Syringes
- International Medical Industries, Inc.Dec 16, 2020
K201031 · NRFit® Caps, Male and Female Neuraxial Tip Caps
- Becton, Dickinson and CompanySep 4, 2020
K192538 · BD Syringe NRFit Lok and BD Syringe NRFit Slip
- Jiangsu Caina Medical Co.,LtdDec 14, 2018
K181374 · NRFit Syringe