Panels › Gastroenterology, Urology › Product code PNR · Class 2
Enteral Syringes With Enteral Specific Connectors
Regulation 876.5980
2510(k)s in 12 months (34 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
Top companies in PNR
| Company | 510(k)s | Recalls |
|---|---|---|
| Cardinal Health 200, LLC | 0 | 4 |
| Covidien | 4 | 0 |
| Neomed, Inc. | 4 | 0 |
| CMT Health PTE., Ltd. | 2 | 0 |
| Jiangsu Caina Medical Co.,Ltd | 2 | 0 |
| Ningbo Tianyi Medical Appliance Co., Ltd. | 2 | 0 |
| Pentaferte Italia S.R.L. | 2 | 0 |
| Shantou Wealy Medical Instrument Co.,Ltd | 2 | 0 |
| Amsino International, Inc. | 1 | 0 |
| Anhui Tiankang Medical Technology Co., Ltd. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 2, 2024 | Cardinal Health 200, LLC Cardinal Health Monoject, 60mL Enteral Syringe (purple) - For Use with ENFit
Connection System, REF 460SE Open, Classified |
PNR | K190502 |
| Feb 2, 2024 | Cardinal Health 200, LLC Cardinal Health Monoject, 35mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 435SE Open, Classified |
PNR | K190502 |
| Feb 2, 2024 | Cardinal Health 200, LLC Cardinal Health Monoject, 12mL Enteral Syringe (purple) For Use with ENFit
Connection System, REF 412SE Open, Classified |
PNR | K190502 |
| Feb 2, 2024 | Cardinal Health 200, LLC Cardinal Health Monoject, 6ML Enteral Syringe (purple) Low Dose (LDT) - For Use with ENFit Connection System, REF 406SE Open, Classified |
PNR | K190502 |
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