VitriThaw

GUDID 05411967001439

VitriThaw™ kit containing the following product codes: - VitriThaw Thawing 1 medium (VT1005) DI number: 05411967002108 - VitriThaw Thawing 2 medium (VT2001) DI number: 05411967002115 - VitriThaw Thawing 3 medium (VT3001) DI number: 05411967002122 - VitriThaw Thawing 4 medium (VT4001) DI number: 05411967002139 VitriThaw™ is a set of cell culture media designed for the thawing of vitrified morula and blastocyst stage human embryos after vitrification with VitriFreeze™ kit VitriThaw™ 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 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: 05411967001439
• NIH Device Record Key: 4e6162d1-e0cc-450c-9a3e-5768adc9a511
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VitriThaw
• Version Model Number: VT_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

• 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	05411967001439 [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 [VitriThaw]

• 54119670021398: VitriThaw™ Thawing 4 (REF: VT4001) (1 ml) Component of VitriThaw™ kit, which are a set of
• 54119670021220: VitriThaw™ Thawing 3 (REF: VT3001) (3 ml) Component of VitriThaw™ kit, which are a set of
• 54119670021152: VitriThaw™ Thawing 2 (REF: VT2001) (1 ml) Component of VitriThaw™ kit, which are a set of
• 54119670021084: VitriThaw™ Thawing 1 (REF: VT1005) (5 ml) Component of VitriThaw™ kit, which are a set of
• 54119670014390: VitriThaw™ kit containing the following product codes: - VitriThaw Thawing 1 medium (VT1005)
• 05411967002139: VitriThaw™ Thawing 4 (REF: VT4001) (1 ml) Component of VitriThaw™ kit, which are a set of
• 05411967002122: VitriThaw™ Thawing 3 (REF: VT3001) (3 ml) Component of VitriThaw™ kit, which are a set of
• 05411967002115: VitriThaw™ Thawing 2 (REF: VT2001) (1 ml) Component of VitriThaw™ kit, which are a set of
• 05411967002108: VitriThaw™ Thawing 1 (REF: VT1005) (5 ml) Component of VitriThaw™ kit, which are a set of
• 05411967001439: VitriThaw™ kit containing the following product codes: - VitriThaw Thawing 1 medium (VT1005)