BIO-FLEX® TESIO®

Basic Information

• Brand Name: BIO-FLEX® TESIO®
• Primary DI: 00884908145779
• Version / Model: DBFLS
• Company Name: Medical Components, Inc.
• Labeler DUNS: 038000253
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-09-11
• Public Version: 3
• Public Version Date: 2022-07-21
• Public Version Status: Update
• Public Device Record Key: 6b0c27c0-74f0-4aa0-b662-dae9b25f0177
• Distribution End Date: 2022-07-13

Device Description

10FX52CM SINGLE BIO-FLEX® TESIO® VENOUS CATHETER TRAY (CUFF 30CM FROM TIP)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	876.5540	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37278	Double-lumen haemodialysis catheter, implantable	An implantable, flexible, double-lumen tube intended to be used for chronic or long-term (> 30 days) vascular access, primarily during haemodialysis, to conduct blood from a patient and returning it after extracorporeal circulation; it may also be used during haemoperfusion and/or apheresis. It is intended for coaxial flow of blood, may be radiopaque, coated with heparin to prevent thrombus formation, and/or include a silver-coated sleeve to retard bacterial growth; devices dedicated to catheter introduction/function (e.g., introducer needle) may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50884908145774	GS1	BOX	5	Not in Commercial Distribution	2022-07-13
Primary	00884908145779	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]