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.

• 00893727002934 - Modified Ham's F-10 with Albumin: 2024-02-12 Modified Ham's F-10 w/Albumin
• 00893727002941 - Modified Ham's F-10 with Albumin: 2024-02-12 Modified Ham's F-10 w/Albumin
• 00893727002835 - Modified Ham's F-10 Basal Medium - HEPES: 2023-12-08 Modified Ham's F-10 Basal Medium - HEPES
• 00857515006337 - Heavy Oil for Embryo Culture: 2022-07-21 Heavy Oil for Embryo Culture
• 00857515006344 - Heavy Oil for Embryo Culture: 2022-07-21 Heavy Oil for Embryo Culture
• 00893727002248 - Early Cleavage Medium: 2022-03-31 Early Cleavage Medium (ECM) with Gentamicin
• 00893727002989 - Polyvinylpyrrolidone (PVP) - Lyophilized: 2022-01-06 PVP (polyvinylpyrrolidone)
• 00893727002286 - Complete Early Cleavage Medium with DSS: 2021-10-20 Complete Early Cleavage (ECM) With DSS