Irrigation Set

Basic Information

• Brand Name: Irrigation Set
• Primary DI: 04046964368745
• Version / Model: V4008
• Catalog Number: V4008
• Company Name: B. BRAUN MEDICAL INC.
• Labeler DUNS: 002397347
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 5
• Public Version Date: 2020-09-04
• Public Version Status: Update
• Public Device Record Key: 44d3c679-397c-4e42-bca6-35894f23512d

Device Description

Irrigation/Urology Set, Non-vented Spike and Distal Foley Catheter Connector

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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LJH	System, irrigation, urological	Gastroenterology, Urology	876.5130	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46102	Surgical irrigation tubing set, single-use	A collection of flexible, noninvasive, single-lumen tubing and associated items intended to provide a conduit to deliver a sterile irrigation solution (e.g., saline) from its source (e.g., gravity feed bag, feed pump) to a surgical cannula (not included) during a surgical procedure (endoscopy, laparoscopy); it is not intended to navigate through an anatomical lumen. The tubing set includes devices such as clamps, filters, spikes, and Y-piece connectors, and may in addition include an integrated manual pump (e.g., a squeeze bulb) or handpiece. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04046964368745	GS1
Unit of Use	04046964368738	GS1

Customer Contacts

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