Intussusception Air Reduction Kit with Blue tip

Basic Information

• Brand Name: Intussusception Air Reduction Kit with Blue tip
• Primary DI: 00860002476100
• Version / Model: IARK-3
• Catalog Number: IARK-3
• Company Name: GRI MEDICAL PRODUCTS INC
• Labeler DUNS: 005875146
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-12-18
• Public Version: 1
• Public Version Date: 2019-12-26
• Public Version Status: New
• Public Device Record Key: e8089414-5417-4919-9324-51a1088623f0

Device Description

Intussusception Air Reduction Kit with Pink Tip

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KQT	Evacuator, Gastro-Urology	Gastroenterology, Urology	876.4370	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35050	Gravity enema set	A collection of devices intended to be used to deliver an injection of fluid (e.g., saline solution) into the rectum to facilitate evacuation of the large intestine. It includes a fluid reservoir (e.g., enema bag) which acts as a gravity-flow chamber, and typically includes enema tube(s) and enema tip; it may be prefilled with a non-medicated enema solution and may be available preassembled. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860002476100	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]