FLEXI-SEAL PROTECT FMS 421630

GUDID 00768455143016

FLEXI-SEAL PROTECT Fecal Management System

CONVATEC, PURCHASING DEPARTMENT

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