AccessGUDID - DEVICE: Chang Medium® C with Gentamicin (00857515006054)

GUDID

Device Identifier (DI) Information

Brand Name: Chang Medium® C with Gentamicin
Version or Model: 99418-450mL
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 99418
Company Name: FUJIFILM IRVINE SCIENTIFIC, INC.

Primary DI Number: 00857515006054
Issuing Agency: GS1
Commercial Distribution End Date: September 30, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 057475246 *Terms of Use

Device Description: Chang Medium C with Gentamicin

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:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
60095	Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent	A substance or reactant intended to be used for the suspension, preservation and storage of amnioic fluid and/or chorionic villus sample (CVS) fluid of a clinical specimen, in order to maintain suitability for karyotyping or chromosome evaluation.	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
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 450 Milliliter

Device Record Status

Public Device Record Key: 6fb3a5da-26f1-4c26-a402-340146d9d03c
Public Version Date: September 30, 2020
Public Version Number: 4
DI Record Publish Date: December 31, 2017