AccessGUDID - DEVICE: ZTMV™ (G507ZTMV05000)

GUDID

Device Identifier (DI) Information

Brand Name: ZTMV™
Version or Model: ZTMV0500
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: ZTMV0500
Company Name: Incell Corporation, LLC

Primary DI Number: G507ZTMV05000
Issuing Agency: HIBCC
Commercial Distribution End Date: October 18, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 965420953 *Terms of Use

Device Description: GMP Transport Media for Viruses with Gentamicin, Clindamycin, Amphotericin B

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KIT	Media And Components, Synthetic Cell And Tissue Culture

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 2 and 8 Degrees Celsius
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 500 Milliliter

Device Record Status

Public Device Record Key: 59247e63-47e1-4399-a99f-69646f3d66a0
Public Version Date: October 19, 2023
Public Version Number: 2
DI Record Publish Date: September 01, 2023