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510(k) Data Aggregation
K Number
K233477Device Name
Cryo-straw (Type I, Type III); Warming Kit (A-4ML, B-8ML); Vitrification Kit (A-3ML, B-6ML)
Manufacturer
Date Cleared
2024-07-01
(249 days)
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
Shandong Wego Ruisheng Medical Device Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Vitrification Kit is indicated for use in the vitrification of oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
The Warming Kit is indicated for use in the thawing of vitrified oocvtes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos, and blastocyst stage embryos.
The Cryo-straw is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain vitrified oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos, and blastocyst stage embrvos.
Device Description
The Vitrification Kit and Warming Kit are assisted reproduction technology (ART) media products for freezing and thawing oocytes (MII), pronuclear (PN) zygotes through Day 3 cleavage stage embryos, and blastocyst stage embryos.
There are two models for each Vitrification Kit and Warming Kit. The difference is the volume of the solutions in the kits. The solutions in the "A" model for each kit are in 1 ml vials, and the solutions in the "B" model are in 2 ml vials. Each model contains two sets of kit media.
The Vitrification Kit includes three sequential media components, Washing solution (WS), Equilibrium solution (ES), and Vitrification solution (VS), containing the cryoprotectants ethylene glycol, dimethyl sulfoxide, and sucrose. Using this methodology, the permeating cryoprotectants can replace water in the oocyte and PN through blastocyst stage embryos prior to vitrification and storage in liquid nitrogen.
The Warming Kit is composed of three media used sequentially for thawing and removing cryoprotectants from vitrified oocytes and PN through blastocyst stage embryos. The Warming Kit is composed of Thaw solution (TS), Diluent solution (DS), and Washing solution (WS).
All media in the Vitrification Kit and Warming Kit undergo aseptic filtration and are single-use only.
The Cryo-Straw is a single-use, sterile, cryopreservation storage device for holding and maintaining vitrified oocytes (MII) and pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos. There are two models for the Cryo-straws: Type I and Type III, and each has 5 colors: brown, orange, blue, red, green. The Cryo-straws are composed of a rod and sheath with a combined length of 132.5 mm. The Type I model has a flat slide and the Type III model has a curved slide for sample loading. The Cryo-straws are sterilized using gamma radiation.
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