Chang Medium® C with Gentamicin For Human Amniotic Fluid Cells 99419

GUDID 00893727002750

FUJIFILM IRVINE SCIENTIFIC, INC.

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

• Primary Device ID: 00893727002750
• NIH Device Record Key: 5067add5-40a9-4bf8-9f48-69ec1d2c918b
• Commercial Distribution Discontinuation: 2020-09-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Chang Medium® C with Gentamicin For Human Amniotic Fluid Cells
• Version Model Number: 99419-500mL
• Catalog Number: 99419
• 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: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00893727002750 [Primary]

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: 2020-10-07
• Device Publish Date: 2020-09-29

On-Brand Devices [Chang Medium® C with Gentamicin For Human Amniotic Fluid Cells]

• 00857515006047: Chang Medium C with Gentamicin
• 00893727002750: 99419-500mL