VitriFreeze

GUDID 05411967001415

VitriFreeze™ kit containing the following product codes: - VitriFreeze Pre-incubation medium (VPI005) DI number: 05411967002054 - VitriFreeze Freezing 1 medium (VF1001) DI number: 05411967002030 - VitriFreeze Freezing 2 medium (VF2001) DI number: 05411967002047 VitriFreeze™ is a set of cell culture media designed for the vitrification of morula and blastocyst stage human embryos. VitriFreeze™ media have a 12 month shelf life. For the latest version of the instructions for use or MSDS, visit the product page on our website (www.fertipro.com).

Fertipro NV

IVF medium

• Primary Device ID: 05411967001415
• NIH Device Record Key: 306fcbd3-9e1d-46fd-b92c-0122c4911718
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VitriFreeze
• Version Model Number: VF_KIT1
• Company DUNS: 373904101
• Company Name: Fertipro NV
• 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: false
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +3250791805
• Email: info@fertipro.com
• Phone: +3250791805
• Email: info@fertipro.com
• Phone: +3250791805
• Email: info@fertipro.com
• Phone: +3250791805
• Email: info@fertipro.com
• Phone: +3250791805
• Email: info@fertipro.com
• Phone: +3250791805
• Email: info@fertipro.com
• Phone: +3250791805
• Email: info@fertipro.com
• Phone: +3250791805
• Email: info@fertipro.com
• Phone: +3250791805
• Email: info@fertipro.com
• Phone: +3250791805
• Email: info@fertipro.com
• Phone: +3250791805
• Email: info@fertipro.com
• Phone: +3250791805
• Email: info@fertipro.com
• Phone: +3250791805
• Email: info@fertipro.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	05411967001415 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070135

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: 3
• Public Version Date: 2019-12-10
• Device Publish Date: 2016-09-19

On-Brand Devices [VitriFreeze]

• 54119670020544: VitriFreeze™ Pre-incubation medium (REF: VPI005) (5 ml) Component of VitriFreeze™ kit, whi
• 54119670020476: VitriFreeze™ Freezing 2 (REF: VF2001) (1 ml) Component of VitriFreeze™ kit, which are a se
• 54119670020308: VitriFreeze™ Freezing 1 (REF: VF1001) (1 ml) Component of VitriFreeze™ kit, which are a se
• 54119670014154: VitriFreeze™ kit containing the following product codes: - VitriFreeze Pre-incubation medium
• 05411967002054: VitriFreeze™ Pre-incubation medium (REF: VPI005) (5 ml) Component of VitriFreeze™ kit, whi
• 05411967002047: VitriFreeze™ Freezing 2 (REF: VF2001) (1 ml) Component of VitriFreeze™ kit, which are a se
• 05411967002030: VitriFreeze™ Freezing 1 (REF: VF1001) (1 ml) Component of VitriFreeze™ kit, which are a se
• 05411967001415: VitriFreeze™ kit containing the following product codes: - VitriFreeze Pre-incubation medium