SepMate-15

Basic Information

• Brand Name: SepMate-15
• Primary DI: 07540207854158
• Version / Model: 85415
• Catalog Number: 85415
• Company Name: Stemcell Technologies Canada Inc
• Labeler DUNS: 252152400
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2022-10-21
• Public Version: 2
• Public Version Date: 2023-09-22
• Public Version Status: Update
• Public Device Record Key: 3c0bb0f2-b306-42aa-a1e9-c6b11c0ae97e

Device Description

SepMate is a tube used to isolate mononuclear cells (MNCs, comprising lymphocytes and monocytes) from human whole blood or bone marrow by density centrifugation.

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: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JCF	Lymphocyte Separation Medium	Hematology	864.8500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
43761	Centrifuge tube IVD	A tube intended to be used in the laboratory to contain a clinical specimen, reagent, or other material associated with in vitro diagnostic testing, for separation by centrifugation. It is designed to be placed in a centrifuge rotor for the procedure; it may also be placed in a rack for short-term storage of its contents. It is typically transparent to facilitate observation of its contents, frequently includes a cap (e.g., screw or press-fit), and may have graduations along the side. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	17540207854155	GS1
Primary	07540207854158	GS1

Customer Contacts

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