Chang Medium BMC with Gentamicin

Basic Information

• Brand Name: Chang Medium BMC with Gentamicin
• Primary DI: 00857515006153
• Version / Model: 91004-500ML
• Catalog Number: 91004
• Company Name: FUJIFILM IRVINE SCIENTIFIC, INC.
• Labeler DUNS: 057475246
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-04-20
• Public Version: 1
• Public Version Date: 2021-04-28
• Public Version Status: New
• Public Device Record Key: 055598e8-a31c-4c2e-a59e-90a220a6fe00

Device Description

Chang Medium BMC with Gentamicin

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KIQ	Kit, Culture, Chromosome	Hematology	864.2260	1
KIT	Media And Components, Synthetic Cell And Tissue Culture	Hematology	864.2220	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60095	Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent	A substance or reactant intended to be used for the suspension, preservation and storage of amnioic fluid and/or chorionic villus sample (CVS) fluid of a clinical specimen, in order to maintain suitability for karyotyping or chromosome evaluation.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00857515006153	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Total Volume	500	Milliliter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – -10 Degrees Celsius