FLEXI-SEAL PROTECT FMS 421630

GUDID 00768455143016

FLEXI-SEAL PROTECT Fecal Management System

CONVATEC, PURCHASING DEPARTMENT

Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit

• Primary Device ID: 00768455143016
• NIH Device Record Key: b6440e00-3372-4621-b9d6-a730785013f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FLEXI-SEAL PROTECT FMS
• Version Model Number: 421630
• Catalog Number: 421630
• Company DUNS: 809784593
• Company Name: CONVATEC, PURCHASING DEPARTMENT
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00768455143016 [Primary]
GS1	10768455143013 [Package]; Package: Shipper [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181206

FDA Product Code

• EZQ: POUCH, COLOSTOMY
• KNT: Tubes, Gastrointestinal (And Accessories)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-05-12

On-Brand Devices [FLEXI-SEAL PROTECT FMS]

• 00768455143016: FLEXI-SEAL PROTECT Fecal Management System
• 30768455143017: FLEXI-SEAL PROTECT Fecal Management System