Continuous Single Culture®–NX (CSCM–NX) 90167

GUDID 00857515006221

Continuous Single Culture®–NX (CSCM–NX)

FUJIFILM IRVINE SCIENTIFIC, INC.

IVF medium

• Primary Device ID: 00857515006221
• NIH Device Record Key: 7175b844-8bee-40bf-848e-775cf6d1afd7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Continuous Single Culture®–NX (CSCM–NX)
• Version Model Number: 90167-60ML
• Catalog Number: 90167
• Company DUNS: 057475246
• Company Name: FUJIFILM IRVINE SCIENTIFIC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Dimensions

• Total Volume: 60 Milliliter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857515006221 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170681

FDA Product Code

• MQL: Media, Reproductive

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-13
• Device Publish Date: 2017-07-28

On-Brand Devices [Continuous Single Culture®–NX (CSCM–NX)]

• 00857515006221: Continuous Single Culture®–NX (CSCM–NX)
• 00857515006214: Continuous Single Culture®–NX (CSCM–NX)