AccessGUDID - DEVICE: VitriThaw (05411967001439)

GUDID

Device Identifier (DI) Information

Brand Name: VitriThaw
Version or Model: VT_KIT1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Fertipro NV

Primary DI Number: 05411967001439
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 373904101 *Terms of Use

Device Description: VitriThaw™ kit containing the following product codes: - VitriThaw Thawing 1 medium (VT1005) DI number: 05411967002108 - VitriThaw Thawing 2 medium (VT2001) DI number: 05411967002115 - VitriThaw Thawing 3 medium (VT3001) DI number: 05411967002122 - VitriThaw Thawing 4 medium (VT4001) DI number: 05411967002139 VitriThaw™ is a set of cell culture media designed for the thawing of vitrified morula and blastocyst stage human embryos after vitrification with VitriFreeze™ kit VitriThaw™ media have a 12 month shelf life. For the latest version of the instructions for use or MSDS, visit the product page on our website: www.fertipro.com

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:	Yes
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 [?]
K070135	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
Special Storage Condition, Specify: Keep away from sunlight
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4e6162d1-e0cc-450c-9a3e-5768adc9a511
Public Version Date: June 24, 2024
Public Version Number: 4
DI Record Publish Date: September 19, 2016