Ultra RapidWarm Blast

GUDID 07350025914251

Vitrolife Sweden AB

IVF medium

• Primary Device ID: 07350025914251
• NIH Device Record Key: 160e41fb-dc5f-4910-838e-9ffbd066e93c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultra RapidWarm Blast
• Version Model Number: 10150
• Company DUNS: 631805488
• Company Name: Vitrolife Sweden AB
• Device Count: 4
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350025914251 [Unit of Use]
GS1	17350025914258 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240605

FDA Product Code

• MQL: Media, Reproductive

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-09-24
• Device Publish Date: 2024-09-16

Devices Manufactured by Vitrolife Sweden AB

• 07350025914251 - Ultra RapidWarm Blast: 2024-09-24
• 07350025914251 - Ultra RapidWarm Blast: 2024-09-24
• 17350025915682 - Follicle Aspiration Set Reduced Single Lumen: 2024-07-10
• 17350025915699 - Follicle Aspiration Set Single Lumen: 2024-07-10
• 07350025910901 - EmbryoGlue: 2022-02-07
• 07350025910765 - HYASE-10X: 2022-01-10
• 07350025910833 - HYASE-10X: 2021-07-01
• 07350025910796 - G-RINSE: 2021-06-04
• 07350025910802 - ASP: 2021-06-04