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 ID: 00857515006627
• NIH Device Record Key: cc906c94-e486-425d-800c-987bd35c6f55
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Thawing NX - TS
• Version Model Number: 90179-2X20ML
• Catalog Number: 90179
• Company DUNS: 057475246
• Company Name: FUJIFILM IRVINE SCIENTIFIC, INC.
• Device Count: 2
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857515006627 [Primary]
GS1	10857515006624 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190152

FDA Product Code

• MQL: Media, Reproductive

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-06
• Device Publish Date: 2024-05-29

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