cryo-GO Vitrification Device 70309-B

GUDID 00857515006672

Blue Vitrification Device (Pack of 10) cryo-GO Vitrification Device is a cryopreservation device intended for use in vitrification procedures to contain and maintain human oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocysts stage embryos.

FUJIFILM IRVINE SCIENTIFIC, INC.

Assisted reproduction vitrification carrier

• Primary Device ID: 00857515006672
• NIH Device Record Key: 2da06253-ef5e-497a-959f-31acc721e54d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: cryo-GO Vitrification Device
• Version Model Number: 70309-B
• Catalog Number: 70309-B
• 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: true
• 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
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857515006672 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241341

FDA Product Code

• MQK: Labware, Assisted Reproduction

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: 2024-10-31
• Device Publish Date: 2024-10-23

On-Brand Devices [cryo-GO Vitrification Device]

• 00857515006740: Purple Vitrification Device (Pack of 50) cryo-GO Vitrification Device is a cryopreservation devi
• 00857515006733: Green Vitrification Device (Pack of 50) cryo-GO Vitrification Device is a cryopreservation devic
• 00857515006726: Blue Vitrification Device (Pack of 50) cryo-GO Vitrification Device is a cryopreservation device
• 00857515006719: Yellow Vitrification Device (Pack of 50) cryo-GO Vitrification Device is a cryopreservation devi
• 00857515006702: Red Vitrification Device (Pack of 50) cryo-GO Vitrification Device is a cryopreservation device
• 00857515006696: Purple Vitrification Device (Pack of 10) cryo-GO Vitrification Device is a cryopreservation devi
• 00857515006689: Green Vitrification Device (Pack of 10) cryo-GO Vitrification Device is a cryopreservation devic
• 00857515006672: Blue Vitrification Device (Pack of 10) cryo-GO Vitrification Device is a cryopreservation device
• 00857515006665: Yellow Vitrification Device (Pack of 10) cryo-GO Vitrification Device is a cryopreservation devi
• 00857515006658: Red Vitrification Device (Pack of 10) cryo-GO Vitrification Device is a cryopreservation device