Fresh Cells

Basic Information

• Brand Name: Fresh Cells
• Primary DI: 30014613333340
• Version / Model: 57-4824
• Catalog Number: 57-4824
• Company Name: DIAGNOSTIC HYBRIDS, INC.
• Labeler DUNS: 117359612
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-21
• Public Version: 2
• Public Version Date: 2023-06-29
• Public Version Status: Update
• Public Device Record Key: 1ebfff4e-f021-4ada-9beb-0add430608b0

Device Description

HEP2 PLATE W48/24F

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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
KIR	CELLS, ANIMAL AND HUMAN, CULTURED	Hematology	864.2280	1

GMDN Terms

Code	Name	Definition	Implantable	Status
30670	Cell culture line IVD	A cell line of known origin intended to be used alone or in combination with other IVDs, for cytogenetic analyses and/or for the detection/cultivation of viruses present in clinical laboratory specimens.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	30014613333340	GS1

Customer Contacts

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