AccessGUDID - DEVICE: VitaVitro (06971982050007)

GUDID

Device Identifier (DI) Information

Brand Name: VitaVitro
Version or Model: Jd-1.0
Commercial Distribution Status: In Commercial Distribution
Catalog Number: V003001, V003002
Company Name: SHENZHEN VITAVITRO BIOTECH CO.,LTD.

Primary DI Number: 06971982050007
Issuing Agency: GS1
Commercial Distribution End Date: December 05, 2026
Device Count: 1
Labeler D-U-N-S® Number*: 544504573 *Terms of Use

Device Description: No description.

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):	No
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?
47445	Assisted reproduction vitrification kit	A collection of reusable/consumable devices used for the vitrification (cryopreservation) and recovery of biological specimens (e.g., eggs, embryos) in assisted reproduction procedures. It is typically used by embryologists/medical scientists to perform ultra-rapid cooling of a specimen without immersion/contact of the specimen with liquid nitrogen (LN2), and enables subsequent warming to recover the specimen. It typically consists of a highly-conductive metal block with surfaces/slots used for the vitrification process, a cryobath for the LN2 in which the block is placed, plastic carriers to hold and store the specimen, and pipetting devices.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MQL	Media, Reproductive

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K180073	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: 70d4b20c-97fd-4e0d-8b97-a7ecec267ae6
Public Version Date: February 19, 2025
Public Version Number: 4
DI Record Publish Date: December 05, 2018