CryotopUS-flash(Y) 81185

GUDID 14582231462831

Cryopreservation storage devices that are intended for use in vitrificationprocedures to contain and maintain human oocytes (MII) and embryos.

KITAZATO CORPORATION

Assisted reproduction vitrification carrier

• Primary Device ID: 14582231462831
• NIH Device Record Key: bdf3e495-2ef9-43a6-bd11-260cd1823be0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CryotopUS-flash(Y)
• Version Model Number: CryotopUS-flash(Y)
• Catalog Number: 81185
• Company DUNS: 711091157
• Company Name: KITAZATO CORPORATION
• 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04582231462834 [Primary]
GS1	14582231462831 [Package]; Contains: 04582231462834; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181469

FDA Product Code

• MQK: LABWARE, ASSISTED REPRODUCTION

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-01-08
• Device Publish Date: 2019-06-01

Devices Manufactured by KITAZATO CORPORATION

• 14573316384773 - Ultra-Fast Warm: 2025-09-05
• 14573316385107 - Ultra-Fast Vitri: 2025-09-05
• 14573316385114 - Ultra-Fast Vitri: 2025-09-05
• 14573316385978 - Ultra-Fast Vitri: 2025-09-05
• 14573316385985 - Ultra-Fast Vitri: 2025-09-05
• 14573316386012 - Ultra-Fast Vitri: 2025-09-05
• 14573316386029 - Ultra-Fast Vitri: 2025-09-05
• 14573316386173 - ES(Equilibration Solution) Pack 4 vials: 2024-12-03 ES(Equilibration Solution) Pack 4x1.5ml vials