Tubifast®

Basic Information

• Brand Name: Tubifast®
• Primary DI: 05055158008960
• Version / Model: 3557
• Company Name: Mölnlycke Health Care AB
• Labeler DUNS: 631770658
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-11-03
• Public Version: 1
• Public Version Date: 2023-11-13
• Public Version Status: New
• Public Device Record Key: 07ffc064-e22c-44bf-840f-b2ccec245e66

Device Description

Tubifast 2-Way Stretch Yellow 5m 10x6pcs

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FQM	BANDAGE, ELASTIC	General Hospital	880.5075	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61652	Tubular support bandage, non-latex, reusable	A tubular, elastic non-latex fabric (e.g., polyamide, Lycra) sleeve intended to be externally worn on a limb to provide support or local pressure to a part of the body, especially a joint, for various preventative/therapeutic applications (e.g., support soft tissue injuries) while enabling movement. Sometimes referred to as a tubigrip, it may be designed to accommodate one or more anatomies (e.g., ankles, knees, wrists). It is not designed specifically to apply an even or graduated force to the limb (i.e., not a compression/pressure garment). This is a single-patient, reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	07332551940270	GS1	CASE	10	In Commercial Distribution
Package	05055158008977	GS1	PACK_OR_INNER_PACK	6	In Commercial Distribution
Primary	05055158008960	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Yellow