EasySep™ Buffer

Basic Information

• Brand Name: EasySep™ Buffer
• Primary DI: 07540207107803
• Version / Model: 100-0780
• Catalog Number: 100-0780
• Company Name: Stemcell Technologies Canada Inc
• Labeler DUNS: 252152400
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-02-08
• Public Version: 1
• Public Version Date: 2024-02-16
• Public Version Status: New
• Public Device Record Key: 219e3ea0-8310-4f18-9f07-306fbd1cc24c

Device Description

EasySep™ Buffer is a cell separation buffer required for use with EasySep™ IVD Cell Isolation Kit. It contains Dulbecco’s phosphate-buffered saline (PBS) with 2% fetal bovine serum (FBS) and 1 mM EDTA.

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: 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
JCC	Ph Buffer	Pathology	864.4010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42651	Buffered isotonic saline reagent IVD	A buffered isotonic saline solution intended to be used alone or in combination with other IVDs in the processing, staining, and/or testing of clinical laboratory specimens.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07540207107803	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius