Qora AIM Stool Management Kit

Basic Information

• Brand Name: Qora AIM Stool Management Kit
• Primary DI: 00860974000303
• Version / Model: MG-01975-002
• Company Name: Consure Medical Private Limited
• Labeler DUNS: 650869782
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-10
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 15f222a6-f92e-421b-9ffb-46e5b1cdbbc2

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: Yes
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• 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
47039	Faecal incontinence kit	A collection of devices used for the conveyance and collection of liquid/semi-liquid stool (faeces) from the rectum to a collection bag for a patient who is unable to control stool discharge. It typically includes a balloon catheter, a disposable collection bag, a syringe, connectors, and ports for balloon inflation and irrigation. The catheter is inserted into the rectum where it is retained by the inflatable balloon for a prescribed length of time. The kit is appropriate for adult patients in an intensive care unit (ICU), other acute care settings, or for persons with a disability. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860974000303	GS1