Chang Medium® C with Gentamicin 99418

GUDID 00857515006054

Chang Medium C with Gentamicin

FUJIFILM IRVINE SCIENTIFIC, INC.

Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent
Primary Device ID00857515006054
NIH Device Record Key6fb3a5da-26f1-4c26-a402-340146d9d03c
Commercial Distribution StatusIn Commercial Distribution
Brand NameChang Medium® C with Gentamicin
Version Model Number99418-450mL
Catalog Number99418
Company DUNS057475246
Company NameFUJIFILM IRVINE SCIENTIFIC, INC.
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 Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com

Device Dimensions

Total Volume450 Milliliter
Total Volume450 Milliliter
Total Volume450 Milliliter
Total Volume450 Milliliter
Total Volume450 Milliliter
Total Volume450 Milliliter
Total Volume450 Milliliter
Total Volume450 Milliliter
Total Volume450 Milliliter
Total Volume450 Milliliter
Total Volume450 Milliliter
Total Volume450 Milliliter
Total Volume450 Milliliter
Total Volume450 Milliliter
Total Volume450 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100857515006054 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-02-13
Device Publish Date2017-12-31

Devices Manufactured by FUJIFILM IRVINE SCIENTIFIC, INC.

00893727002620 - Multipurpose Handling Medium® (MHM®)2025-03-31 Multipurpose Handling Medium® with Gentamicin
00893727002637 - Multipurpose Handling Medium® (MHM®)2025-03-31 Multipurpose Handling Medium® with Gentamicin
00893727002644 - Continuous Single Culture®2025-03-31 Continuous Single Culture® with Gentamicin
00893727002651 - Continuous Single Culture® Complete with Gentamicin Sulfate with Human Serum Alb2025-03-31 Continuous Single Culture® Complete with HSA
00893727002712 - Multipurpose Handling Medium®-Complete (MHM®-C)2025-03-31 Multipurpose Handling Medium®-Complete (MHM®-C) with Gentamicin
00893727002729 - Multipurpose Handling Medium®-Complete (MHM®-C)2025-03-31 Multipurpose Handling Medium®-Complete (MHM®-C) with Gentamicin
00857515006658 - cryo-GO Vitrification Device2024-10-31 Red Vitrification Device (Pack of 10) cryo-GO Vitrification Device is a cryopreservation device intended for use in vitrificatio
00857515006665 - cryo-GO Vitrification Device2024-10-31 Yellow Vitrification Device (Pack of 10) cryo-GO Vitrification Device is a cryopreservation device intended for use in vitrifica

Trademark Results [Chang Medium]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CHANG MEDIUM
CHANG MEDIUM
73342083 1244971 Live/Registered
Hana Media, Inc.
1981-12-17

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