ISolate® 99264

GUDID 00857515006009

ISolate

FUJIFILM IRVINE SCIENTIFIC, INC.

IVF medium

• Primary Device ID: 00857515006009
• NIH Device Record Key: 55a9c42a-9e9d-4a78-afaf-af8c13b7d063
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ISolate®
• Version Model Number: 99264-2x100mL
• Catalog Number: 99264
• Company DUNS: 057475246
• Company Name: FUJIFILM IRVINE SCIENTIFIC, INC.
• Device Count: 2
• 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: 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

Device Dimensions

• Total Volume: 100 Milliliter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857515006009 [Primary]
GS1	10857515006006 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991341

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: 2016-09-10

Devices Manufactured by FUJIFILM IRVINE SCIENTIFIC, INC.

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• 00857515006672 - cryo-GO Vitrification Device: 2024-10-31 Blue Vitrification Device (Pack of 10) cryo-GO Vitrification Device is a cryopreservation device intended for use in vitrificati
• 00857515006689 - cryo-GO Vitrification Device: 2024-10-31 Green Vitrification Device (Pack of 10) cryo-GO Vitrification Device is a cryopreservation device intended for use in vitrificat
• 00857515006696 - cryo-GO Vitrification Device: 2024-10-31 Purple Vitrification Device (Pack of 10) cryo-GO Vitrification Device is a cryopreservation device intended for use in vitrifica
• 00857515006702 - cryo-GO Vitrification Device: 2024-10-31 Red Vitrification Device (Pack of 50) cryo-GO Vitrification Device is a cryopreservation device intended for use in vitrificatio
• 00857515006719 - cryo-GO Vitrification Device: 2024-10-31 Yellow Vitrification Device (Pack of 50) cryo-GO Vitrification Device is a cryopreservation device intended for use in vitrifica
• 00857515006726 - cryo-GO Vitrification Device: 2024-10-31 Blue Vitrification Device (Pack of 50) cryo-GO Vitrification Device is a cryopreservation device intended for use in vitrificati