TransFix

Basic Information

• Brand Name: TransFix
• Primary DI: 05060531710026
• Version / Model: TFB-01
• Catalog Number: TFB-01-1, TFB-1-10, TFB-01-50
• Company Name: CALTAG MEDSYSTEMS LIMITED
• Labeler DUNS: 221434843
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-22
• Public Version: 1
• Public Version Date: 2023-10-02
• Public Version Status: New
• Public Device Record Key: 1254587f-391d-4a4d-bf5f-c274dbabe1d0

Device Characteristics

• Single Use: No
• 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
PPM	General Purpose Reagent	Pathology	864.4010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
52735	Cell preservation/storage/dilution solution IVD	A solution intended to be used for the preservation, storage, washing, dilution and/or resuspension of cells (e.g., red and/or white blood cells, epithelial, bacterial, fungal, etc.) in a clinical specimen or a cell isolate, to maintain cell stability and/or facilitate further in vitro diagnostic testing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060531710026	GS1
Package	15060531710023	GS1	Foil Pouch	1	In Commercial Distribution
Package	25060531710020	GS1	Foil Pouch	10	In Commercial Distribution
Package	35060531710027	GS1	Foil Pouch	50	In Commercial Distribution

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 25 Degrees Celsius