RUSCH

Basic Information

• Brand Name: RUSCH
• Primary DI: 24026704066128
• Version / Model: IPN044966
• Catalog Number: 546231-000000
• Company Name: TELEFLEX INCORPORATED
• Labeler DUNS: 002348191
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-16
• Public Version: 3
• Public Version Date: 2018-12-10
• Public Version Status: Update
• Public Device Record Key: bf28e5f0-6c95-475a-af4d-73eb26f07d34

Device Description

Adhesive patch, big

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: 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
KOB	CATHETER, SUPRAPUBIC (AND ACCESSORIES)	Gastroenterology, Urology	876.5090	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59024	Universal patient tubing holder, non-sterile	A small, non-sterile device with a locking/holding mechanism designed to secure tubing or tubing-like devices (e.g., cables, cords) to a patient or to a surgical drape during a clinical intervention. It is typically designed as: 1) an adhesive pad (plaster), strip, or bandage intended to attach to the patient's skin or drape with the exposed side having an integrated fixation mechanism (e.g., Velcro hook/loop closure); or 2) a mechanical closure or gripping system intended to hold the tubing or tubing hub in place. It is not designed to hold a specific type or brand of tubing. This is a single-patient device that may be reapplied over a short term (single-use) before being discarded.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	44026704066122	GS1	Carton	10	In Commercial Distribution
Primary	24026704066128	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K952187	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight; Keep dry