Vit Kit - Freeze NX 90188

GUDID 00857515006320

Vit Kit - Freeze NX

FUJIFILM IRVINE SCIENTIFIC, INC.

IVF medium kit

• Primary Device ID: 00857515006320
• NIH Device Record Key: b22e823b-ac66-4305-823c-28f9308b9724
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vit Kit - Freeze NX
• Version Model Number: 90188
• Catalog Number: 90188
• 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: true
• Device Combination Product: false
• Single Use: true
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857515006320 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190152

FDA Product Code

• MQL: Media, Reproductive

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: 2019-07-22
• Device Publish Date: 2019-07-12

Devices Manufactured by FUJIFILM IRVINE SCIENTIFIC, INC.

• 00893727002200 - Freezing Medium - TEST Yolk Buffer (TYB) with Glycerol and Gentamicin: 2025-04-14 Freezing Medium With Gentamicin
• 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