SYMETREX® MBPS023GL

GUDID 50884908146658

15.5F X 23CM SYMETREX® LONG TERM HEMODIALYSIS CATHETER SET W/STYLETS (CUFF 23CM FROM TIP)

Medical Components, Inc.

Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable

• Primary Device ID: 50884908146658
• NIH Device Record Key: 60befe89-cb06-4e5a-9ac3-2a89bd7ddb7b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SYMETREX®
• Version Model Number: MBPS023GL
• Catalog Number: MBPS023GL
• Company DUNS: 038000253
• Company Name: Medical Components, Inc.
• 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: true
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(215)256-4201
• Email: clinical@medcompnet.com
• Phone: +1(215)256-4201
• Email: clinical@medcompnet.com
• Phone: +1(215)256-4201
• Email: clinical@medcompnet.com
• Phone: +1(215)256-4201
• Email: clinical@medcompnet.com
• Phone: +1(215)256-4201
• Email: clinical@medcompnet.com
• Phone: +1(215)256-4201
• Email: clinical@medcompnet.com
• Phone: +1(215)256-4201
• Email: clinical@medcompnet.com
• Phone: +1(215)256-4201
• Email: clinical@medcompnet.com
• Phone: +1(215)256-4201
• Email: clinical@medcompnet.com
• Phone: +1(215)256-4201
• Email: clinical@medcompnet.com
• Phone: +1(215)256-4201
• Email: clinical@medcompnet.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884908146653 [Primary]
GS1	50884908146658 [Package]; Contains: 00884908146653; Package: box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202176

FDA Product Code

• MSD: Catheter, hemodialysis, implanted

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-08
• Device Publish Date: 2022-07-29

On-Brand Devices [SYMETREX®]

• 50884908146764: 15.5F X 23CM SYMETREX® LONG TERM HEMODIALYSIS CATHETER SET W/O STYLET (CUFF 23CM FROM TIP)
• 50884908146757: 15.5F X 19CM SYMETREX® LONG TERM HEMODIALYSIS CATHETER SET W/O STYLET (CUFF 19CM FROM TIP)
• 50884908146658: 15.5F X 23CM SYMETREX® LONG TERM HEMODIALYSIS CATHETER SET W/STYLETS (CUFF 23CM FROM TIP)
• 50884908146641: 15.5F X 19CM SYMETREX® LONG TERM HEMODIALYSIS CATHETER SET W/STYLETS (CUFF 19CM FROM TIP)