Kangaroo

Basic Information

• Brand Name: Kangaroo
• Primary DI: 10192253007077
• Version / Model: 388105E
• Catalog Number: 388105E
• Company Name: Cardinal Health 200, LLC
• Labeler DUNS: 961027315
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-06-15
• Public Version: 1
• Public Version Date: 2022-06-23
• Public Version Status: New
• Public Device Record Key: 4d3d7cb7-7392-4142-88de-200d98f96a96

Device Description

ENFIT INSUFFLATION DEVICE

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KNT	Tubes, gastrointestinal (and accessories)	Gastroenterology, Urology	876.5980	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62063	Endoscopic insufflation tubing set, reusable	A collection of flexible tubing intended to be used as a conduit to deliver a medical gas [e.g., carbon dioxide (CO2), medical air] from its source into a body cavity for insufflation during endoscopy (e.g., gastrointestinal endoscopy, laparoscopy, arthroscopy). It includes synthetic polymer tubing and associated connectors, and may include additional tubing for delivery of a sterile irrigation solution for endoscopic irrigation. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50192253007075	GS1	CASE	5	In Commercial Distribution
Primary	10192253007077	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius