ClearanceBrief
Panels › General Hospital › Product code LZH · Class 2

Pump, Infusion, Enteral

Regulation 880.5725

1510(k)s in 12 months (34 all time)
0recalls in 12 months (24 all time)
24recalls that name a 510(k)
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Top companies in LZH

DateFirm and productCodeLinked 510(k)
Jan 19, 2021Cardinal Health 200, LLC
Enteral Infusion Pump
Completed
LZHK040196
Sep 22, 2020Cardinal Health 200, LLC
Kangaroo Connect 1000ml Bag Set, Non-Sterile, Product Code 77100FD - Product Usage: single-use tubing sets used with pumps in the delivery of nutritional feeding product.
Open, Classified
LZHK153074
Sep 22, 2020Cardinal Health 200, LLC
Kangaroo Connect 500ml Bag Set, Non-Sterile, Product Code 77500FD - Product Usage: single-use tubing sets used with pumps in the delivery of nutritional feeding product.
Open, Classified
LZHK153074
Dec 26, 2019Cardinal Health Inc.
Kangaroo 924 Safety Screw Spike Set, Product Code 775759
Open, Classified
LZHK141479
Dec 26, 2019Cardinal Health Inc.
Kangaroo Epump Safety Screw Spike Set, Anti-free Flow, Product Code 775659
Open, Classified
LZHK040196
Dec 26, 2019Cardinal Health Inc.
Kangaroo Epump Safety Screw Spike with Flush Bag, Anti-free Flow, 1000 mL, Product Code 775100
Open, Classified
LZHK040196
Dec 26, 2019Cardinal Health Inc.
Kangaroo Connect ENPlus Spike Set Anti-free Flow, Product Code 77000FD
Open, Classified
LZHK153074
Dec 26, 2019Cardinal Health Inc.
Kangaroo Joey Safety Screw Spike Set, Anti-free Flow, Product Code 765559
Open, Classified
LZHK040196
K141479 +1
Dec 26, 2019Cardinal Health Inc.
Kangaroo Joey Safety Screw Spike with Flush Bag, Anti-free Flow,1000 mL, Product Code 765100
Open, Classified
LZHK040196
K141479 +1
Apr 1, 2016Medtronic
Covidien Kangaroo Connect Enteral Feeding Pump Item Number: 584400 (OUS) Intended to provide enteral nutrition to a patient for hospital and acute care settings.
Terminated
LZHK143263
Apr 1, 2016Medtronic
Covidien Kangaroo Connect Enteral Feeding Pump Item Number: 384400 (US) Intended to provide enteral nutrition to a patient for hospital and acute care settings.
Terminated
LZHK143263
Jan 31, 2013MOOG Medical Devices Group
Infinity Enteralite Ambulatory Feeding Pumps, List number: INFKIT2 - Addendum to Operator's Manual Product usage: provide a means for the volumetric delivery of fluids used in Enteral applications.
Terminated
LZHK031199
Nov 15, 2012MOOG Medical Devices Group
EnteraLite Infinity Enteral Feeding Pump identified with the following list numbers: INFKIT2 and INFORNG. The device is used with disposable PVC administration tubing sets to provide a means for the
Terminated
LZHK031199
Oct 25, 2011CORPAK MedSystems
CORFLO 300 Enteral Pump; a volumetric rotary peristaltic intermittent enteral feeding pump; CORPAK MedSystems, Wheeling, IL 60090; catalog/reorder #20-0500. Intended to deliver formula to patients re
Terminated
LZHK944750
Sep 21, 2009Abbott Nutrition, Abbott Laboratories
Flexiflo Quantum Enteral Pump Model # 50596, 50598 and 59322. The Flexiflo Quantum enteral pump is a medical device that is used to deliver enteral nutrition products to tube-fed patients. The pumps
Terminated
LZHK913958
Sep 21, 2009Zevex International, Inc.
Infinity Orange Enteral Feeding Pump, REF INFORNG, Zevex Enteral Nutrition Delivery Systems, Salt Lake City, UT 84123.
Terminated
LZHK031199
Sep 21, 2009Zevex International, Inc.
EnteraLite Infinity Enteral Feeding Pump, REF INFP01, Zevex Enteral Nutrition Delivery Systems, Salt Lake City, UT 84123. A rotary peristaltic pump designed to deliver programmed doses of enteral nut
Terminated
LZHK031199
Sep 20, 2008Abbott Laboratories
Flexiflo Quantum Pump Set with Piercing Pin and Flush Bag The product is used with Quantum pump to deliver ready-to-hang (RTH) product in enterally-fed patients.
Terminated
LZHK915735
Aug 8, 2007Ross Products Division Abbott Laboratories
Embrace Enteral Pump
Terminated
LZHK031407
Aug 7, 2007Ross Products Division Abbott Laboratories
The Companion ClearStar Pump System, for enteral feeding.
Terminated
LZHK981541
Mar 8, 2005Ross Products Division Abbott Laboratories
Flexiflo Quantum Enteral Pump
Terminated
LZHK944669
Mar 5, 2003Novartis Nutrition Corp
Compat DualFlo Enteral Delivery Pump Set with 1000-mL Twist Cap Formula Vinyl Bag and 1000-mL Twist Cap Water Bag, Item number 19944700
Terminated
LZHK940555
Mar 5, 2003Novartis Nutrition Corp
Compat 500 mL Baggle Top Fill Enteral Feeding Container with Preattached Enteral Delivery Pump Set, Item number 19931200
Terminated
LZHK940556
Mar 5, 2003Novartis Nutrition Corp
Compat Enteral Delivery Pump Set with Piercing Spike, Item number 19930700
Terminated
LZHK940556

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