AccessGUDID - DEVICE: Kangaroo (30884521022106)

GUDID

Device Identifier (DI) Information

Brand Name: Kangaroo
Version or Model: 773662
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 773662
Company Name: Cardinal Health, Inc.

Primary DI Number: 30884521022106
Issuing Agency: GS1
Commercial Distribution End Date: February 28, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 080935429 *Terms of Use

Device Description: Epump Set with Flush Bag,Anti-free Flow

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:	No
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?
64461	Enteral feeding noninvasive-component set	A collection of devices such as tubing, connectors, chambers, clamps, and bags/bottles intended to be used to create the noninvasive (i.e., fully external) portion of an enteral feeding device assembly; it is not intended for intravenous (IV) administration. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LZH	PUMP, INFUSION, ENTERAL

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: ;

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 1000 Milliliter

Device Record Status

Public Device Record Key: 7b4a7508-47aa-4bbe-8c5d-052fc2d330d5
Public Version Date: February 28, 2023
Public Version Number: 9
DI Record Publish Date: September 24, 2016