CHANG Medium D T105

GUDID 00810195240637

CHANG Medium D with L-Glutamine. 500mL bottle.

IRVINE SCIENTIFIC, LLC

Cell culture medium IVD
Primary Device ID00810195240637
NIH Device Record Keya5449150-5730-47d3-a4c8-93bfb4f1c05c
Commercial Distribution StatusIn Commercial Distribution
Brand NameCHANG Medium D
Version Model NumberT105-500ML
Catalog NumberT105
Company DUNS121584789
Company NameIRVINE SCIENTIFIC, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100810195240637 [Primary]

FDA Product Code

KITMedia And Components, Synthetic Cell And Tissue Culture

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-10
Device Publish Date2025-06-02

On-Brand Devices [CHANG Medium D]

00810195240637CHANG Medium D with L-Glutamine. 500mL bottle.
00810195240620CHANG Medium D with L-Glutamine. 100mL bottle.

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