Thawing NX - TS 90179

GUDID 00857515006627

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.

FUJIFILM IRVINE SCIENTIFIC, INC.

IVF medium kit
Primary Device ID00857515006627
NIH Device Record Keycc906c94-e486-425d-800c-987bd35c6f55
Commercial Distribution StatusIn Commercial Distribution
Brand NameThawing NX - TS
Version Model Number90179-2X20ML
Catalog Number90179
Company DUNS057475246
Company NameFUJIFILM IRVINE SCIENTIFIC, INC.
Device Count2
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100857515006627 [Primary]
GS110857515006624 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQLMedia, Reproductive

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-06
Device Publish Date2024-05-29

Devices Manufactured by FUJIFILM IRVINE SCIENTIFIC, INC.

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