AccessGUDID - DEVICE: V-OIL (04260650071331)

GUDID

Device Identifier (DI) Information

Brand Name: V-OIL
Version or Model: V-OIL-500P
Commercial Distribution Status: In Commercial Distribution
Catalog Number: V-OIL-500P
Company Name: VITROMED GmbH

Primary DI Number: 04260650071331
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315234102 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QKI	Media, Reproductive, Exempt

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 105d8dd7-763b-4f66-9034-5f204d5e136f
Public Version Date: April 12, 2022
Public Version Number: 1
DI Record Publish Date: April 04, 2022