RUSCH

Basic Information

• Brand Name: RUSCH
• Primary DI: 04026704072514
• Version / Model: IPN052232
• Catalog Number: 395763-000140
• Company Name: TELEFLEX INCORPORATED
• Labeler DUNS: 002348191
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: c929dcc2-e21c-4cf9-9e7a-05e375f912d5

Device Description

Rectal Catheter

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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
FAP	CYSTOMETRIC GAS (CARBON-DIOXIDE) ON HYDRAULIC DEVICE	Gastroenterology, Urology	876.1620	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55837	Urodynamic catheter	A long, thin, sterile, flexible or semi-rigid tube designed for connection to urodynamic measuring equipment for urodynamic examination of a patient. It is inserted into the bladder via the urethra or non-surgically via a stoma for cystometry, to drain the bladder to facilitate measurement of urinary output, and for urethral pressure and other urethral and voiding pressure examinations. It is available with various lumens (e.g., single, double, triple) providing one or more openings at the distal end, and is calibrated in increments to assist in positioning. It may be dedicated to a gas or water infusion technique. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	54026704072519	GS1	Case	12	In Commercial Distribution
Package	24026704072518	GS1	Box	10	In Commercial Distribution
Primary	04026704072514	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K962472	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	4.7	Millimeter