Enteroclysis Catheter 13Fx155cm

Basic Information

• Brand Name: Enteroclysis Catheter 13Fx155cm
• Primary DI: 30815112021093
• Version / Model: 901501
• Catalog Number: 901501
• Company Name: Bracco Diagnostics Inc.
• Labeler DUNS: 849234661
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-19
• Public Version: 6
• Public Version Date: 2025-05-26
• Public Version Status: Update
• Public Device Record Key: 953b5dca-38fa-4aa6-8c9c-0c75d6d82c8e
• Distribution End Date: 2021-01-01

Device Description

Enteroclysis Cath 13F w/Ball

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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EZK	Catheter, Retention Type	Gastroenterology, Urology	876.5980	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34912	Barium enema catheter	A flexible tube designed to administer barium, a contrast medium, into the lower gastrointestinal tract by way of the rectum, for radiographic visualization of the area; it may additionally be intended for washing of the colon. The rubber or plastic tube may also be used for colonoscopy and can have a silicone rubber retention balloon tip for the examination of incontinent persons. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50815112021097	GS1	Box	24	Not in Commercial Distribution	2021-01-01
Primary	30815112021093	GS1

Customer Contacts

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