Retention Cuff Inflator

Basic Information

• Brand Name: Retention Cuff Inflator
• Primary DI: 10815112021228
• Version / Model: 900405
• Catalog Number: 900405
• Company Name: BRACCO DIAGNOSTICS INC
• Labeler DUNS: 849234661
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 12
• Record Status: Published
• Publish Date: 2023-05-25
• Public Version: 1
• Public Version Date: 2023-06-02
• Public Version Status: New
• Public Device Record Key: 8d72e699-64c8-4505-a47e-e4ad70168e13

Device Description

One Shot Cuff Inflator

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
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. 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
Unit of Use	00815112021221	GS1
Primary	10815112021228	GS1
Package	30815112021222	GS1	Box	12	In Commercial Distribution

Customer Contacts

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