VitriFreeze

GUDID 05411967002054

VitriFreeze™ Pre-incubation medium (REF: VPI005) (5 ml) Component of VitriFreeze™ kit, which are a set of cell culture media designed for the vitrification of morula and blastocyst stage human embryos. For more information, see DI Number of VitriFreeze kit: 05411967001415 The medium has 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 IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium

• Primary Device ID: 05411967002054
• NIH Device Record Key: 1d2792c1-7e0c-4597-9745-1eed92cd1dd7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VitriFreeze
• Version Model Number: VPI005
• 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: false
• 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
• 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
• Phone: +3250791805
• Email: info@fertipro.com

Device Dimensions

• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter

Operating and Storage Conditions

• 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
• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05411967002054 [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