Singapore HSA registration DE0508342
Cardinal Health Kangaroo™ OMNI™ Enteral Feeding System
Singapore·CLASS B·Cardinal Health 200 LLC·Registered July 28, 2023Device 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 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.
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
About this record
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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