Chang Medium MF with Gentamicin 91005

GUDID 00857515006160

FUJIFILM IRVINE SCIENTIFIC, INC.

Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent

• Primary Device ID: 00857515006160
• NIH Device Record Key: da66b95d-683e-4a60-b68f-bd7286645693
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Chang Medium MF with Gentamicin
• Version Model Number: 91005-500ML
• Catalog Number: 91005
• Company DUNS: 057475246
• Company Name: FUJIFILM IRVINE SCIENTIFIC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com

Device Dimensions

• Total Volume: 500 Milliliter
• Total Volume: 500 Milliliter
• Total Volume: 500 Milliliter
• Total Volume: 500 Milliliter
• Total Volume: 500 Milliliter
• Total Volume: 500 Milliliter
• Total Volume: 500 Milliliter
• Total Volume: 500 Milliliter
• Total Volume: 500 Milliliter
• Total Volume: 500 Milliliter
• Total Volume: 500 Milliliter
• Total Volume: 500 Milliliter
• Total Volume: 500 Milliliter
• Total Volume: 500 Milliliter
• Total Volume: 500 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857515006160 [Primary]

FDA Product Code

• KIT: Media And Components, Synthetic Cell And Tissue Culture

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-27
• Device Publish Date: 2021-04-19

On-Brand Devices [Chang Medium MF with Gentamicin]

• 00893727002408: 91005-100ML
• 00857515006160: 91005-500ML