ZTMV™

Basic Information

• Brand Name: ZTMV™
• Primary DI: G507ZTMV01000
• Version / Model: ZTMV0100
• Catalog Number: ZTMV0100
• Company Name: Incell Corporation, LLC
• Labeler DUNS: 965420953
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-01
• Public Version: 2
• Public Version Date: 2023-10-19
• Public Version Status: Update
• Public Device Record Key: 59b514fa-ad83-4ec1-96e9-c847f5c98515
• Distribution End Date: 2023-10-18

Device Description

GMP Transport Media for Viruses with Gentamicin, Clindamycin, Amphotericin B

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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• 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	G507ZTMV01000	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	100	Milliliter

Storage Conditions

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