Search Results
Found 3 results
510(k) Data Aggregation
K Number
K242561Device Name
Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit)
Manufacturer
DonneVie Medical Technology (Shanghai) Co. Ltd.
Date Cleared
2025-04-10
(225 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
DonneVie Medical Technology (Shanghai) Co. Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dewin Vitrification Kit is intended for use in the vitrification of oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
Dewin Thawing Kit is intended for use in the thawing of vitrified oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
Device Description
Dewin Vitrification Kit and Dewin Thawing Kit include a set of five media intended for use in the vitrification and thawing of oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos, and blastocyst stage embryos as part of InVitro Fertilization (IVF) procedures.
The Vitrification Kit and Thawing Kit media are offered in 2mL and 5mL volumes. Dewin Vitrification Kit includes two media components, Equilibration Solution (ES) and Vitrification Solution (VS), containing the cryoprotectants ethylene glycol, trehalose (only in VS), and dimethyl sulfoxide. During the vitrification process, embryos are first exposed to ES and then to VS. Using this methodology, the permeating cryoprotectants can replace water in the oocyte or PN through blastocyst stage embryos prior to vitrification and storage in liquid nitrogen.
Dewin Thawing Kit is composed of three media used stepwise for thawing and removing cryoprotectants from vitrified oocytes and PN through blastocyst stage embryos. It is composed of Thawing Solution (TS), Dilution Solution (DS) and Washing Solution (WS).
The primary ingredients of the vitrification and thawing media are water, sodium chloride, potassium chloride, sodium dihydrogen phosphate dihydrate, magnesium sulphate heptahydrate, calcium chloride, sodium bicarbonate, gentamicin sulfate, glucose, sodium-s-lactate, sodium pyruvate, alanyl glutamine, taurine, EDTA, phenol red, HEPES, HSA, trehalose, ethylene glycol, DMSO, non-essential amino acids. Cryoprotectants in the media include ethylene glycol (7.5% in ES, 15% in VS), DMSO (7.5% in ES, 15% in VS), and trehalose in VS, TS and DS.
The five solutions in the Dewin Vitrification Kit and Dewin Thawing Kit are aseptically filtered (storage vials sterilized by dry heat and radiation) and provided in glass bottles capped with a polypropylene screw-top cap. They are single-use only and have a shelf-life of 7 months when stored at 2-8°C.
Ask a Question
K Number
K231370Device Name
Dewin Blastocyst Medium (with HSA and without HSA)
Manufacturer
DonneVie Medical Technology (Shanghai) Co. Ltd.
Date Cleared
2023-08-04
(84 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
DonneVie Medical Technology (Shanghai) Co. Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dewin Blastocyst Medium (with HSA and without HSA) is intended for culture from the 8-cell stage to the blastocyst stage of embryo development. Dewin Blastocyst Medium (with HSA) is also intended for use in transfer of blastocyst stage embryos into the uterine cavity.
Device Description
Dewin Blastocyst Medium (with HSA and without HSA) is intended for embryo culture from the cleavage to blastocyst stage of development and can also be used for transfer of blastocyst stage embryos to the uterine cavity.
Dewin Blastocyst Medium is comprised of salts, buffering agents, energy substrates, antioxidant, vitamins, nutrient supplements, amino acids, and gentamicin. Dewin Blastocyst Medium is offered with and without Human Serum Albumin (HSA).
Dewin Blastocyst Medium (with HSA and without HSA) is aseptically filtered and filled into glass bottles with polypropylene caps. The device is provided in 25 mL and 50 mL volumes. Dewin Blastocyst Medium (with HSA and without HSA) has a four-month shelf-life when stored as recommended and is for singleuse only.
Ask a Question
K Number
K212426Device Name
Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and Dewin Cleavage Medium [with HSA and without HSA])
Manufacturer
DonneVie Medical Technology (Shanghai) Co. Ltd.
Date Cleared
2022-06-16
(316 days)
Product Code
MQL, MOL
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
DonneVie Medical Technology (Shanghai) Co. Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dewin Reproductive Media consists of Dewin Fertilization Medium (with HSA and without HSA) and Dewin Cleavage Medium (with HSA and without HSA). The indications for use for the Dewin Fertilization Medium and Dewin Cleavage Medium are as follows:
Dewin Fertilization Medium is intended for use during in vitro fertilization (IVF) procedures and culture to the two pronuclei (zygote) stage of development. Dewin Fertilization Medium is also intended for washing sperm and collected oocytes after aspiration prior to IVF procedures. Dewin Fertilization Medium is not intended for use in intrauterine insemination procedures.
Dewin Cleavage Medium is intended for culture of embryos from the two pronuclei (zygote) stage of embryo development. Dewin Cleavage Medium is also intended for use in the transfer of cleavage stage embryos into the uterine cavity.
Device Description
Dewin Reproductive Media includes two products (Dewin Fertilization and Dewin Cleavage Medium). Dewin Fertilization Medium is intended for use in washing sperm and oocytes for use in in IVF procedures. Dewin Cleavage Medium, is intended for use in culturing embryos from the zygote stage to the 8-cell stage of development and can also be used for embryo transfer procedures.
Dewin Reproductive Media are comprised of salts, energy substrates, anti-oxidant, nutrient supplements, amino acids, EDTA, gentamicin, and phenol red. Dewin Reproductive Media are offered with and without Human Serum Albumin (HSA).
The Dewin Reproductive Media are aseptically filtered and filled into glass bottles with polypropylene caps. The devices are provided in 25 mL and 50 mL volumes. Dewin Reproductive Media have a fourmonth shelf-life when stored as recommended and are for single-use only.
Ask a Question
Page 1 of 1