PIF · Class II · 21 CFR 876.5980

FDA Product Code PIF: Gastrointestinal Tubes With Enteral Specific Connectors

To Facilitate Enteral Specific Connections.

Leading manufacturers include Covidien, Medline Industries, Inc. and Xeridiem Medical Devices, A Spectrum Plastics Group Company.

51
Total
51
Cleared
171d
Avg days
2014
Since
51 devices
25–48 of 51
Cleared Nov 07, 2019
Salem Sump Dual Lumen Stomach Tube with ENFit Connection
K190923
Cardinalhealth
Gastroenterology & Urology · 212d
Cleared Jun 14, 2019
Moss Gastrostomy Tube, Moss Nasal Tube – Mark IV
K190414
Moss Tubes, Inc.
Gastroenterology & Urology · 113d
Cleared May 31, 2019
U Deliver Bolink ENFit Enteral Feeding Sets
K190310
U Deliver Medical, LLC
Gastroenterology & Urology · 108d
Cleared Apr 25, 2019
Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding Tubes
K181787
Cedic S.R.L.
Gastroenterology & Urology · 294d
Cleared Apr 09, 2019
ENConnect 40 mm Screw Cap to ENPlus Adapter
K190327
Cedic S.R.L.
Gastroenterology & Urology · 55d
Cleared Oct 18, 2018
Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube with ENFit Connection, Entuit LP Patient Care Kit, Entuit LP Patient Care Kit with ENFit Connection, PromaX Low Profile Gastrostomy Feeding Tube, PromaX LP Patient Care Kit with ENFit
K180708
Xeridiem Medical Devices, A Spectrum Plastics Group Company
Gastroenterology & Urology · 213d
Cleared Jul 12, 2018
CONOD Enteral Feeding Sets
K181276
Conod Medical Co., Limited
Gastroenterology & Urology · 59d
Cleared Sep 26, 2017
Vesco Medical Nasoenteric Feeding Tubes
K170162
Vesco Medical, LLC
Gastroenterology & Urology · 251d
Cleared Aug 17, 2017
U Deliver Bolink ENFit Enteral Feeding Sets
K170555
U Deliver Medical, LLC
Gastroenterology & Urology · 174d
Cleared Jun 06, 2017
Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection, Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection
K171347
Xeridiem Medical Devices
Gastroenterology & Urology · 29d
Cleared Mar 17, 2017
Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit Connector
K163586
Trovrx, Inc. Dba Trovita Health Science
Gastroenterology & Urology · 87d
Cleared Mar 02, 2017
Edi Catheter ENFit
K153688
Maquet Critical Care AB
Gastroenterology & Urology · 435d
Cleared Nov 29, 2016
Medline ENFit Syringe
K160642
Medline Industries, Inc.
Gastroenterology & Urology · 267d
Cleared Jun 17, 2016
EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, EndoVive Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector, EndoVive Button Right Angle Feeding Set with ENFit Connector, EndoVive Button Bolus Feeding Set with ENFit Connector, EndoVive Button Decompression Tube with ENFit Connector
K161003
Boston Scientific Corporation
Gastroenterology & Urology · 67d
Cleared Apr 05, 2016
NUTRICARE-ISOSAF NASO-GASTRIC FEEDING TUBE
K151503
Gbuk Enteral Limited
Gastroenterology & Urology · 306d
Cleared Oct 08, 2015
Salem Sump Dual Lumen Stomach Tube with Multi-functional Port
K150711
Covidien
Gastroenterology & Urology · 203d
Cleared Jul 13, 2015
Argyle¿ Polyvinyl Chloride (PVC) and Kangaroo¿ Polyurethane (PU) Neonatal and Pediatric Feeding Tubes with ENFit connector
K150084
Covidien
Gastroenterology & Urology · 179d
Cleared May 29, 2015
EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector
K150679
Boston Scientific Corp
Gastroenterology & Urology · 73d
Cleared Apr 27, 2015
Medline Enteral Feeding Sets
K150286
Medline Industries, Inc.
Gastroenterology & Urology · 81d
Cleared Apr 02, 2015
Kangaroo Enteral Feeding Tube Extension Set with ENFit Small Bore Connectors
K143018
Covidien
Gastroenterology & Urology · 164d
Cleared Jan 29, 2015
Mini ONE Enteral Extension Set
K142989
Applied Medical Technology, Inc.
Gastroenterology & Urology · 105d
Cleared Jan 08, 2015
BI-FUNNEL GASTROSTOMY FEEDING TUBE, TRI-FUNNEL GASTROSTOMY FEEDING TUBE
K142075
Xeridiem (Formerly Mri)
Gastroenterology & Urology · 161d
Cleared Jan 08, 2015
Endo Vive 3S Low Profile Balloon Kit, Endo Vive 3S Bolus Extension Sets, Endo Vive 3S Continuous Extension Sets, Endo Vive 3S Medication Extension Set
K142297
Xeridiem (Formerly Mri)
Gastroenterology & Urology · 143d
Cleared Jan 08, 2015
EnteraLite Infinity Enteral Pump Delivery Set, 1200 mL Enteral Feeding Delivery Set
K142539
Zevex, Inc.
Gastroenterology & Urology · 121d