AccessGUDID - DEVICE: Kangaroo (10884521165021)

GUDID

Device Identifier (DI) Information

Brand Name: Kangaroo
Version or Model: 388104
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 388104
Company Name: Cardinal Health, Inc.

Primary DI Number: 10884521165021
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: Mounting Clamp 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?
43621	Desk mount	A non-dedicated (general-purpose) manually-operated structure designed to be fixed to a desk or a worktop and onto which another medical device (not included) is intended to be safely affixed or mounted. This device is typically clamped (i.e., removable) or permanently screwed to the desk or a worktop surface.	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
Special Storage Condition, Specify: Keep dry;

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: No;

Device Record Status

Public Device Record Key: a5eec998-2d66-4204-9eba-557d59b00e1e
Public Version Date: February 03, 2023
Public Version Number: 10
DI Record Publish Date: September 24, 2016