AccessGUDID - DEVICE: Thawing NX - TS (00857515006627)

GUDID

Device Identifier (DI) Information

Brand Name: Thawing NX - TS
Version or Model: 90179-2X20ML
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 90179
Company Name: FUJIFILM IRVINE SCIENTIFIC, INC.

Primary DI Number: 00857515006627
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 057475246 *Terms of Use

Device Description: Vit Kit - Warm NX is an adaptable, cost-effective system for use in the thawing of oocytes, pronuclear zygotes, cleavage stage embryos, and blastocyst stage embryos. Unlike many vitrification kits that feature a mono-buffered system and M199 base medium originally formulated for chick embryo fibroblasts, Vit Kit - Warm NX is derived from current IVF media tailored specifically for human embryo culture. The backbone of Vit Kit - Warm NX is Continuous Single Culture medium, an IVF medium intended for conventional fertilization and culture from Day 1 and beyond. Similar to our Multipurpose Handling Medium, Vit Kit-NX takes advantage of two buffers, HEPES and MOPS, to provide a more secure pH environment for oocytes and embryos during vitrification. The integration of these key ingredients delivers consistent results, including high oocyte and embryo survival rates, while also offering an effective, flexible, and economical media ideally suited for the nuanced needs of the modern IVF laboratory.

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:	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?
42850	IVF medium kit	A collection of solutions used to provide 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 solutions typically contain various combinations of salts, carbohydrates, amino acids, enzymes, hormones, albumin, vitamins, and/or drugs (e.g., antibiotics). Some included solutions may indirectly support the IVF process. 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 [?]
Premarket Submission Number Not Available/Not Released

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
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: cc906c94-e486-425d-800c-987bd35c6f55
Public Version Date: June 16, 2025
Public Version Number: 2
DI Record Publish Date: May 29, 2024