AccessGUDID - DEVICE: V-VITFREEZE (04260650070327)

GUDID

Device Identifier (DI) Information

Brand Name: V-VITFREEZE
Version or Model: V-FS-KIT
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: VITROMED GmbH

Primary DI Number: 04260650070327
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 3
Labeler D-U-N-S® Number*: 315234102 *Terms of Use

Device Description: V-VITFREEZE is a ready-to-use kit to cryopreserve human oocytes and embryos (up to blastocyst stage) in Assisted Reproduction Technology (ART). There are in total 3 vials of pink solutions in the package: -1 vial of Equilibration Solution (ES), with a blue cap and label. - 2 vials of Vitrification Solution (VS), with green caps and labels. V-VITFREEZE is intended for use in the vitrification of oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.

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:	No
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
MQL	Media, Reproductive

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K240176	000

Device Exempt from Premarket Submission: No 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: 0132d66a-f172-45e9-88c4-c5768936acb5
Public Version Date: October 24, 2024
Public Version Number: 1
DI Record Publish Date: October 16, 2024