cryo-GO Vitrification Device

Basic Information

• Brand Name: cryo-GO Vitrification Device
• Primary DI: 00857515006702
• Version / Model: 70312-R
• Catalog Number: 70312-R
• Company Name: FUJIFILM IRVINE SCIENTIFIC, INC.
• Labeler DUNS: 057475246
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-10-23
• Public Version: 2
• Public Version Date: 2025-03-31
• Public Version Status: Update
• Public Device Record Key: 876ff6b4-47c3-41ad-9c1d-866d40eb9928

Device Description

Red Vitrification Device (Pack of 50) 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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MQK	Labware, Assisted Reproduction	Obstetrics/Gynecology	884.6160	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47446	Assisted reproduction vitrification carrier	A sterile, plastic device used during an assisted reproduction vitrification (cryopreservation) procedure to hold a small volume of vitrification media containing a biological specimen (e.g., egg, embryo) to vitrify (cryopreserve) the specimen, thereby avoiding specimen immersion/contact with LN2. The vitrification process may involve the distal tip/specimen being brought into contact with the surface of a vitrification block [a highly-conductive mass of metal semi-submersed in a liquid nitrogen (LN2) bath]. The device with vitrified specimen is then stored in an LN2 tank, and subsequently transferred into a warming medium to recover the specimen. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00857515006702	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius