EXACTA l Screw Cap Bag: Empty Enema Bag Delivery System

Basic Information

• Brand Name: EXACTA l Screw Cap Bag: Empty Enema Bag Delivery System
• Primary DI: 10815112020832
• Version / Model: 900304
• Catalog Number: 900304
• Company Name: BRACCO DIAGNOSTICS INC
• Labeler DUNS: 849234661
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-19
• Public Version: 3
• Public Version Date: 2020-06-30
• Public Version Status: Update
• Public Device Record Key: ece23fb6-fd42-4763-9b71-2214056dc003

Device Description

Empty Exacta l Bag

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: No
• 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
14194	Enema tube	A non-sterile, length of tubing that is used as a conduit between the enema bag and the enema tip for the delivery of the enema solution into the rectum. It is typically a thick-walled tube and connects to the enema bag at one end and to the enema tip at the other. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10815112020832	GS1
Package	30815112020836	GS1	Box	48	In Commercial Distribution

Customer Contacts

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