Chang Medium B C100

GUDID 00893727002446

CHANG Basal-90ml

FUJIFILM IRVINE SCIENTIFIC, INC.

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

• Primary Device ID: 00893727002446
• NIH Device Record Key: 526f16a5-6f3d-4047-9b15-d86b4539a28c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Chang Medium B
• Version Model Number: C100-90ML
• Catalog Number: C100
• 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

Device Dimensions

• Total Volume: 90 Milliliter
• Total Volume: 90 Milliliter
• Total Volume: 90 Milliliter
• Total Volume: 90 Milliliter
• Total Volume: 90 Milliliter
• Total Volume: 90 Milliliter
• Total Volume: 90 Milliliter
• Total Volume: 90 Milliliter
• Total Volume: 90 Milliliter
• Total Volume: 90 Milliliter
• Total Volume: 90 Milliliter
• Total Volume: 90 Milliliter
• Total Volume: 90 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00893727002446 [Primary]

FDA Product Code

• KIQ: Kit, Culture, Chromosome

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: 2021-04-29
• Device Publish Date: 2021-04-21

Devices Manufactured by FUJIFILM IRVINE SCIENTIFIC, INC.

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• 00893727002361 - ISolate®: 2025-04-14 ISolate
• 00893727002903 - Human Serum Albumin Solution: 2025-04-14 Human Albumin
• 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 Alb: 2025-03-31 Continuous Single Culture® Complete with HSA
• 00893727002712 - Multipurpose Handling Medium®-Complete (MHM®-C): 2025-03-31 Multipurpose Handling Medium®-Complete (MHM®-C) with Gentamicin