FLEXI-SEAL PROTECT PLUS FMS with Luer

GUDID 10768455157157

Flexi-Seal PROTECT PLUS Fecal Management System with Luer connector

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

• Primary Device ID: 10768455157157
• NIH Device Record Key: 678c9a6d-0dc2-493f-a552-aa95a4b5b47f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FLEXI-SEAL PROTECT PLUS FMS with Luer
• Version Model Number: 422303
• Company DUNS: 809784593
• Company Name: CONVATEC, PURCHASING DEPARTMENT
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• 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	00768455157150 [Primary]
GS1	10768455157157 [Package]; Contains: 00768455157150; Package: Shipper [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181206

FDA Product Code

• EZQ: Pouch, Colostomy
• PIF: Gastrointestinal Tubes With Enteral Specific Connectors

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-26
• Device Publish Date: 2019-11-18

Devices Manufactured by CONVATEC, PURCHASING DEPARTMENT

• 00768455204793 - GENTLECATH: 2024-04-15 GENTLECATH AIR FEM V2.0 CH10 1X30PK US
• 00768455204823 - GENTLECATH: 2024-04-15 GENTLECATH AIR FEM V2.0 CH12 1X30PK US
• 00768455204854 - GENTLECATH: 2024-04-15 GENTLECATH AIR FEM V2.0 CH14 1X30PK US
• 00768455207145 - GENTLECATH: 2024-04-15 GENTLECATH AIR FEM V2.0 CH10 1X10PK US
• 00768455207169 - GENTLECATH: 2024-04-15 GENTLECATH AIR FEM V2.0 CH12 1X10PK US
• 00768455207206 - GENTLECATH: 2024-04-15 GENTLECATH AIR FEM V2.0 CH14 1X10PK US
• 10815947021172 - CURE PRODUCTS: 2024-04-08 Cure Hydrophylic, Male, 16”, Straight Tip, Kit
• 10768455203922 - ESTEEM: 2024-03-28 N/A