Rounded Flexi Tip Adult Enema Tip

Basic Information

• Brand Name: Rounded Flexi Tip Adult Enema Tip
• Primary DI: 10815112020993
• Version / Model: 901301
• Catalog Number: 901301
• Company Name: BRACCO DIAGNOSTICS INC
• Labeler DUNS: 849234661
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 12
• Record Status: Published
• Publish Date: 2016-09-19
• Public Version: 5
• Public Version Date: 2020-06-30
• Public Version Status: Update
• Public Device Record Key: 400b293b-2c1c-4d9f-9ad0-e46554a06c06

Device Description

Rounded Flexi Tip

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: 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FGD	Catheter, Retention, Barium Enema With Bag	Gastroenterology, Urology	876.5980	2

GMDN Terms

Code	Name	Definition	Implantable	Status
11583	Enema tip, single-use	A device intended to be connected to an enema tube to facilitate delivery of an enema solution into the rectum; it is not intended to be used during colonic irrigation. It is typically designed as a one-piece, synthetic polymer, moulded nozzle that may have a slight bulb shape at the distal end to improve retention in the rectum. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30815112020997	GS1	Box	24	In Commercial Distribution
Primary	10815112020993	GS1
Unit of Use	00815112020996	GS1

Customer Contacts

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