Kangaroo 461036E

GUDID 10884521742185

Feeding Tube with IRIS Technology. For use with ENFit Connection System. Contains one (1) Stylet per Feeding Tube. ENFit is a federally registered trademark in multiple jurisdictions throughout the wo

Cardinal Health, Inc.

Nasoenteral tube

• Primary Device ID: 10884521742185
• NIH Device Record Key: b8d7b2e8-9459-4903-a7e7-27cdac0b1d64
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kangaroo
• Version Model Number: 461036E
• Catalog Number: 461036E
• Company DUNS: 080935429
• Company Name: Cardinal Health, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Device Dimensions

• Length: 36 Inch
• Length: 36 Inch

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *No
• Special Storage Condition, Specify: Between 0 and 0 *No

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521742185 [Package]; Contains: 20884521742182; Package: CASE [5 Units]; In Commercial Distribution
GS1	20884521742182 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123555

FDA Product Code

• KNT: TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 8
• Public Version Date: 2019-06-17
• Device Publish Date: 2017-07-25

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