RUSCH

Basic Information

• Brand Name: RUSCH
• Primary DI: 14026704645753
• Version / Model: IPN054586
• Catalog Number: 453932
• Company Name: TELEFLEX INCORPORATED
• Labeler DUNS: 002348191
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-06-20
• Public Version: 4
• Public Version Date: 2024-01-11
• Public Version Status: Update
• Public Device Record Key: 9ca5c839-ee76-429f-a7f7-7414dda30ff5

Device Description

RUSCH Large Leg bag with Easy-Tap & PVC Extension Tubing

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• 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
FAQ	BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE	Gastroenterology, Urology	876.5250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58917	Non-wearable adult urine collection bag, closed-ended	A flexible plastic pouch designed to connect to a urinary catheter to collect discharged urine from an adult/adolescent patient; it is not designed with an opening for urine drainage. The device is not directly attached to the patient and is disposed of when full. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	24026704645750	GS1	Box	24	In Commercial Distribution
Primary	14026704645753	GS1

Customer Contacts

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