V-OIL

Basic Information

• Brand Name: V-OIL
• Primary DI: 04260650071133
• Version / Model: V-OIL-500G
• Company Name: VITROMED GmbH
• Labeler DUNS: 315234102
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-04-04
• Public Version: 1
• Public Version Date: 2022-04-12
• Public Version Status: New
• Public Device Record Key: a97a9747-71f9-4c41-acaf-f4ec8b27b27b

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QKI	Media, Reproductive, Exempt	Obstetrics/Gynecology	884.6180	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44046	IVF medium	A solution that provides a physiological environment for the retrieval, culture, maintenance, transfer, and/or storage of human sperm, harvested oocytes (eggs), and/or resulting embryos associated with the method of in vitro fertilization (IVF). The solution typically contains various combinations of salts, carbohydrates, amino acids, enzymes, hormones, albumin, vitamins, and/or drugs (e.g., antibiotics). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	04260650070433	GS1	Board box	1	In Commercial Distribution
Primary	04260650071133	GS1