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Cardinal Health Kangaroo™ OMNI™ Enteral Feeding System - HSA Registration DE0508342

Access comprehensive regulatory information for Cardinal Health Kangaroo™ OMNI™ Enteral Feeding System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508342 and owned by Cardinal Health 200 LLC. The device was registered on July 28, 2023.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS B
DE0508342
Cardinal Health Kangaroo™ OMNI™ Enteral Feeding System
HSA Registration Number: DE0508342
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Product Description

The Kangaroo OMNI™ Enteral Feeding Pump with Kangaroo OMNI™ Feeding Sets are intended for delivery of enteral fluids, including nutritional fluids and/or water to the gastrointestinal system including but not limited to nasogastric, orogastric, nasojejunal, gastrostomy and jejunostomy tubes. Not for use with neonates. They are indicated for use in patients ages infant and older who are physically unable to eat and swallow or who are unable to get sufficient nutrition through eating and swallowing. They are intended to be used in hospital and acute care settings, as well as long term and home care settings by users ranging from clinicians to laypersons and patients. It is intended to be used in both stationary and ambulatory conditions.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Gastroenterology & Urology
Registration Information
Registration Number
DE0508342
Registration Date
July 28, 2023
Change Notification Approval Date
April 10, 2025
Retention Due Date
July 27, 2025
Product Owner
Short Name
Cardinal Health 200 LLC
Address
3651 Birchwood Drive, Waukegan, Illinois 60085, UNITED STATES
Registrant
Address
10 KALLANG AVENUE, APERIA, #10-10/18, SINGAPORE 339510
Importer
Address
10 KALLANG AVENUE, APERIA, #10-10/18, SINGAPORE 339510
Model Information
Model Name(s)
Kangaroo™ OMNI™ Enteral Feeding Pump Kangaroo™ OMNI™ Feeding Set 1000 mL Kangaroo™ OMNI™ Feeding Set with Flush Bag 1000 mL Kangaroo™ OMNI™ Feeding Set 500 mL Kangaroo™ OMNI™ Feeding Set with Flush Bag 500 mL Kangaroo™ OMNI™ Feeding Set with ENPlus Spike Kangaroo™ OMNI™ Feeding Set with Flush Bag and ENPlus Spike 1000mL Kangaroo™ OMNI™ ENtelliSet™ Thick Formula Feeding Set 1000 mL Kangaroo™ OMNI™ ENtelliSet™ Thick Formula Feeding Set with FlushBag 1000 mL Kangaroo™ OMNI™ ENtelliSet™ Thick Formula Feeding Set 500 mL Kangaroo™ OMNI™ ENtelliSet™ Thick Formula Feeding Set with FlushBag 500 mL Kangaroo™ OMNI™ ENtelliSet™ Burette Set 100 mL
Model Identifier(s)
585400 B10FD B10FF B5FD B5FF BSPFD BSPFF E10FDR E10FFR E5FDR E5FFR ER100