Skin Biopsy Transport Medium

Basic Information

• Brand Name: Skin Biopsy Transport Medium
• Primary DI: 00850037506200
• Version / Model: 31067
• Company Name: VERICEL CORPORATION
• Labeler DUNS: 079745570
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-13
• Public Version: 1
• Public Version Date: 2022-12-21
• Public Version Status: New
• Public Device Record Key: dcfdd18b-a81a-4606-a94f-84e02ff5ca34

Device Description

DMEM with Amikacin and Vancomycin

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

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KIT	Media And Components, Synthetic Cell And Tissue Culture	Hematology	864.2220	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58567	Cell culture medium IVD	A liquid based tissue culture medium containing essential nutrients, sugars, amino acids and growth factors, intended to be used for the in-vitro maintenance, sustenance, and cultivation of human cells from a clinical specimen for diagnostic purposes.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850037506200	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Do not freeze