Thawing NX - TS

Basic Information

• Brand Name: Thawing NX - TS
• Primary DI: 00857515006627
• Version / Model: 90179-2X20ML
• Catalog Number: 90179
• Company Name: FUJIFILM IRVINE SCIENTIFIC, INC.
• Labeler DUNS: 057475246
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2024-05-29
• Public Version: 2
• Public Version Date: 2025-06-16
• Public Version Status: Update
• Public Device Record Key: cc906c94-e486-425d-800c-987bd35c6f55

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

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MQL	Media, Reproductive	Obstetrics/Gynecology	884.6180	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00857515006627	GS1
Unit of Use	10857515006624	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius