V-OIL

GUDID 04260650070433

V-OIL is a ready-to-use pre-washed, light paraffin oil for use as an overlay for culture of gametes, zygotes, or embryos in Assisted Reproduction Technology (ART) and micro-manipulation procedure to prevent the evaporation of water and protects the media against changes in osmolality and pH. Culture of embryos in small volumes of medium under oil helps to enhance rates of embryonic development.

VITROMED GmbH

IVF medium

• Primary Device ID: 04260650070433
• NIH Device Record Key: a97a9747-71f9-4c41-acaf-f4ec8b27b27b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: V-OIL
• Version Model Number: V-OIL-500G
• Company DUNS: 315234102
• Company Name: VITROMED GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	04260650070433 [Package]; Contains: 04260650071133; Package: Board box [1 Units]; In Commercial Distribution
GS1	04260650071133 [Primary]

FDA Product Code

• QKI: Media, Reproductive, Exempt

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: 2022-04-12
• Device Publish Date: 2022-04-04

On-Brand Devices [V-OIL]

• 04260650070730: V-OIL is a ready-to-use pre-washed, light paraffin oil for use as an overlay for culture of game
• 04260650070631: V-OIL is a ready-to-use pre-washed, light paraffin oil for use as an overlay for culture of game
• 04260650071232: V-OIL is a ready-to-use pre-washed, light paraffin oil for use as an overlay for culture of game
• 04260650070433: V-OIL is a ready-to-use pre-washed, light paraffin oil for use as an overlay for culture of game