AccessGUDID - DEVICE: Kangaroo (30884521026784)

GUDID

Device Identifier (DI) Information

Brand Name: Kangaroo
Version or Model: 8884742217
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 8884742217
Company Name: Cardinal Health, Inc.

Primary DI Number: 30884521026784
Issuing Agency: GS1
Commercial Distribution End Date: August 18, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 080935429 *Terms of Use

Device Description: Obturator

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
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?
38565	Gastrostomy button	A sterile, short, hollow tube that is inserted into the stomach percutaneously to permit long-term enteral feeding. The tube does not permit reflux and its external end is flush with abdominal skin. This is a single-use device.	Active	true

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;AVOID DIRECT SUNLIGHT

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 20 French

Device Record Status

Public Device Record Key: d874064a-f44d-4b3e-80ff-55f85183980a
Public Version Date: August 18, 2023
Public Version Number: 10
DI Record Publish Date: May 20, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20884521026787	360	30884521026784	2023-08-18	Not in Commercial Distribution	CASE
10884521026780	5	30884521026784	2023-08-18	Not in Commercial Distribution	PACK_OR_INNER_PACK