Rapid-i Kit

GUDID 17350025914395

Vitrolife Sweden AB

Assisted reproduction vitrification carrier

• Primary Device ID: 17350025914395
• NIH Device Record Key: 71b7f44b-b416-4ac7-9ecc-437ad51dcb73
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rapid-i Kit
• Version Model Number: 14406
• Company DUNS: 631805488
• Company Name: Vitrolife Sweden AB
• Device Count: 20
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350025914398 [Unit of Use]
GS1	17350025914395 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090832
• Premarket Notification: K181461

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-13

On-Brand Devices [Rapid-i Kit]

• 17350025914395: 14406
• 17350025912247: 14422
• 17350025912230: 14421
• 17350025912223: 14420
• 17350025912216: 14419