AccessGUDID - DEVICE: Kangaroo (10884521165007)

GUDID

Device Identifier (DI) Information

Brand Name: Kangaroo
Version or Model: 388102
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 388102
Company Name: Cardinal Health, Inc.

Primary DI Number: 10884521165007
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 080935429 *Terms of Use

Device Description: Replacement Battery For use with Kangaroo Feeding Tubes with IRIS Technology

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
36545	Basic power supply, reusable	A device designed to receive alternating-current energy (AC-power) from a mains electricity power line and deliver one or more regulated direct-current outputs to supply devices with electrical energy. It typically consists of a step-up or step-down transformer, a rectifier, a filter, and an electronic regulator that keeps the voltage, current, or power output stable over a broad range of loads and input voltages. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNT	TUBES, GASTROINTESTINAL (AND ACCESSORIES)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 32 and 122 Degrees Fahrenheit
Special Storage Condition, Specify: Keep dry, Do not expose to fire or extreme high temperatures;

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: No;

Device Record Status

Public Device Record Key: f2268721-5821-4766-8fbf-3e132f99dbaa
Public Version Date: February 03, 2023
Public Version Number: 11
DI Record Publish Date: September 24, 2016