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Thawing NX - TS

FDA UDI

Class II (US FDA UDI)

by Fujifilm Irvine Scientific, Inc.

Identity

Trade Name
Thawing NX - TS FDA UDI
Generic Name
IVF medium kit FDA UDI
Device Name
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. FDA UDI
Model / Reference
90179-2X20ML FDA UDI
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. FDA UDI

Identifiers

Catalog Number
90179 FDA UDI
Primary DI / UDI-DI
00857515006627 FDA UDI
FDA Product Code
MQL FDA UDI
GMDN Term
IVF medium kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
884.6180 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: IVF medium kit

Thawing NX - TS by Fujifilm Irvine Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as IVF medium kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Fujifilm Irvine Scientific, Inc.

Sources (1)

  • FDA UDI cc906c94-e486-425d-800c-987bd35c6f55 36 fields · synced Jun 8, 2026