Irrigation Set V4508

GUDID 04046964188794

UniSpike™ Connector, Distal Fol ey Catheter Connector

B. BRAUN MEDICAL INC.

Surgical irrigation tubing set, single-use

• Primary Device ID: 04046964188794
• NIH Device Record Key: 2dc19225-a3b3-4ed3-bc68-4ed3450ebfa0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Irrigation Set
• Version Model Number: V4508
• Catalog Number: V4508
• Company DUNS: 002397347
• Company Name: B. BRAUN MEDICAL INC.
• Device Count: 20
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbra
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04046964188787 [Unit of Use]
GS1	04046964188794 [Primary]

FDA Product Code

• LJH: System, irrigation, urological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-04-23
• Device Publish Date: 2016-09-23

On-Brand Devices [Irrigation Set]

• 04046964368745: Irrigation/Urology Set, Non-vented Sp ike and Distal Foley Catheter Connector
• 04046964291487: UniSpike™ Connector, Distal Fle xible Connector
• 04046964291463: Four-Bag Irrigation Set, Four Non-ven ted Spikes
• 04046964291449: T.U.R./Cysto Set UniSpikeTM Connector
• 04046964291425: SuperSet™ Four-Bottle Irrigatio n Set
• 04046964291401: SuperSet™ Two-Bottle Irrigation Set
• 04046964188879: Continuous Overhead Irrigation Set, Non-vented Spike
• 04046964188794: UniSpike™ Connector, Distal Fol ey Catheter Connector
• 04046964188770: Cysto Post-Operative Irrigation Set
• 04046964188756: T.U.R. Irrigation Connecting Set
• 04046964175794: Two-Bag Irrigation Set, Two Non-vente d Spikes
• 04046964186950: PIC™ Irrigation Container Spike Adaptor