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510(k) Data Aggregation
K Number
K242640Device Name
FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin
Manufacturer
FertiPro Nv
Date Cleared
2025-05-30
(269 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
Product Code :
MQL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
FertiCult™ Flushing medium are intended for in vitro procedures involving human gametes (sperm and oocytes), including washing of gametes, sperm swim-up procedures, intra-uterine insemination (IUI) of the spermatozoa and sperm injection during intracytoplasmic sperm injection (ICSI). FertiCult™ Flushing medium can also be used human embryo washing and holding, and for embryo transfer (ET) in the uterine cavity. The medium is NOT intended for oocyte pick-up and follicle flushing. FertiCult Flushing medium is used during assisted reproductive Technology (ART) procedures of patients and couples undergoing infertility treatments.
Device Description
FertiCult Flushing medium and FertiCult Flushing medium with phenol red and gentamicin intended for in vitro procedures involving human gametes (sperm and oocytes), including washing of gametes, sperm swim-up procedures, intra-uterine insemination (IUI) of the spermatozoa and sperm injection during intracytoplasmic sperm injection (ICSI). FertiCult Flushing media can also be used for human embryo washing and holding, and for embryo transfer (ET) in the uterine cavity.
The base formulation contains Water, Sodium Chloride, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Sulphate Heptahydrate, Sodium Dihydrogen Phosphate Dihydrate, Sodium Pyruvate, Glucose Monohydrate, Sodium Lactate, Sodium hydrogen carbonate, HEPES, Human Serum Albumin.
A FertiCult Flushing media variant contains Phenol red and Gentamicin.
The products can be used up to 7 days after opening, when sterile conditions are maintained, and the products are stored at 2-8°C.
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K Number
K242089Device Name
Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202)
Manufacturer
Jiangsu Ruifuda Medical Device Co., Ltd
Date Cleared
2025-04-10
(267 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
Product Code :
MQL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Vitrification Freeze Kit is intended for use in the vitrification of oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
Vitrification Thaw 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
The Vitrification Freeze Kit is intended for use in the vitrification of oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos, and blastocyst stage embryos during the in vitro assisted reproduction. The Vitrification Freeze Kit includes two solutions: Equilibration Solution (ES) and Vitrification Solution (VS). Both solutions contain ethylene glycol, dimethyl sulfoxide (DMSO), human serum albumin, and Quinn's Advantage® Medium with HEPES. The VS also contains additional sucrose to confer intracellular and extracellular cryoprotective effects. The solutions are available in three specifications: 2 mL, 4.5 mL, and 5 mL, all packaged in polypropylene (pp) vials. The kit includes one vial of each solution.
The Vitrification Thaw 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 during in vitro assisted reproduction. The Vitrification Thaw Kit includes 4 solutions: Thawing Solution 1 (TS1), Thawing Solution 2 (TS2), Thawing Solution 3 (TS3), and Thawing Solution 4 (TS4). All four solutions contain human serum albumin and Quinn's Advantage® Medium with HEPES. TS1 and TS2 also contain sucrose. The solutions are available in three specifications: 2 mL, 4.5 mL, and 5 mL, and 5 mL, all packaged in polypropylene (pp) vials. Model RFD-0201 includes one vial of each solution in the kit, and Model RFD-0202 contains two vials of TS1 and one vial of TS2, TS3, and TS4 each in the kit.
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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?
Product Code :
MQL
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.
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K Number
K241833Device Name
V-GRAD
Manufacturer
VITROMED GmbH
Date Cleared
2025-03-21
(269 days)
Product Code
MQL, MOL
Regulation Number
884.6180Why did this record match?
Product Code :
MQL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
V-GRAD is intended for separation of motile sperm from ejaculates by the density gradient method for use in assisted reproduction procedures.
Device Description
V-GRAD is a sterile colloidal suspension with silicate particles, stabilized with covalently bound hydrophilic silanes that is intended for separation of motile sperm from ejaculates by the density gradient method for use in assisted reproduction procedures. Available as a 100 % stock solution (V-GRAD 100) and as 40% or 80% ready-to-use solutions (V-GRAD 40 and V-GRAD 80) with HEPES buffered Human Tubular Fluid (HTF) medium. V-GRAD 100 is a stock solution for preparing a density gradient system for semen preparation. The V-GRAD Kit consists of two bottles of V-GRAD 40 and V-GRAD 80. V-GRAD is aseptically filtered and provided in pre-sterilized 12 mL glass bottles closed with flourotec rubber stoppers and flip-tear off caps or 100 mL PET(G) bottles closed with HDPE screw caps. V-GRAD has a shelf-life of one year when stored at 2-8°C and can be used for up to seven days after bottle opening.
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K Number
K242107Device Name
CaseMONO Culture (CMON); CaseMONO w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF)
Manufacturer
CaseBioscience, Inc.
Date Cleared
2025-03-21
(246 days)
Product Code
MQL, MOL
Regulation Number
884.6180Why did this record match?
Product Code :
MQL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CaseMONO™ Culture is intended for use for culture of embryos from fertilization to the blastocyst stage. This device can be used for transfer of embryos to the uterus.
CaseBioscience® HTF is intended for use for the culture of embryos to the cleavage stage (Day 3). This device can be used for transfer of embryos to the uterus.
CaseMONO w/HEPES™ is intended for use in short-term handling and manipulating gametes and embryos, including washing and intracytoplasmic sperm injection (ICSI). This medium is not intended for transfering to the uterine cavity.
CaseBioscience® HTF w/HEPES is intended for use in short-term handling gametes embryos, including washing and intracytoplasmic sperm injection (ICSI). This medium is not intended for transferring embryos to the uterine cavitv.
Device Description
CaseMONO Culture, CaseMONO w/HEPES, CaseBioscience HTF, and CaseBioscience HTF w/HEPES are intended for use during in vitro procedures for gamete/embryo culture and one step media.
CaseMONO Culture is intended for use for culture of embryos from fertilization to the blastocyst stage. This device is a one-step media and can be used for transfer of embryos to the uterus.
CaseMONO w/HEPES is intended for use in short-term handling and manipulating gametes and embryos, including washing and intracytoplasmic sperm injection (ICSI).
CaseBioscience HTF is intended for use for the culture of embryos to the cleavage stage (Day 3). This device is not a one-step medium but can be used for transfer of embryos to the uterus.
CaseBioscience HTF w/HEPES is intended for use in short-term handling and manipulating gametes and embryos, including washing and intracytoplasmic sperm injection (ICSI).
CaseMONO Culture and CaseMONO w/HEPES have almost identical composition with differences in amount of NaHCO3 and Phenol red and presence of HEPES in CaseMONO w/HEPES. Similarly, CaseBioscience HTF and CaseBioscience HTF w/HEPES have an almost identical composition with the exception of HEPES present in CaseBioscience HTF w/HEPES and minor difference in composition for NaCl, Sodium L-lactate and Phenol red. CaseMONO Culture and CaseMONO w/HEPES contain EDTA. All media formulations contain antibiotic gentamicin.
The four solutions are aseptically filtered (storage vials sterilized by radiation) and provided in PETG square media bottles with HDPE screw-style caps. They have a shelf-life of 90 days when stored at 2-8°C. Media in the vials can be used for up to seven days after vial opening.
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K Number
K242043Device Name
Sperm Freezing Medium
Manufacturer
Gimbo Medical Technology Shenzhen Co., Ltd.
Date Cleared
2025-01-08
(180 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
Product Code :
MQL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sperm Freezing Medium is intended for the cryopreservation of human semen samples to sperm samples during cryopreservation and thawing prior to use in assisted reproductive technology procedures.
Device Description
Not Found
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K Number
K241095Device Name
ARTSMedia Semen Wash Medium
Manufacturer
ARTSMedia Denmark ApS
Date Cleared
2024-12-18
(240 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
Product Code :
MQL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ARTSMedia Semen Wash Medium (AM Semen Wash) is intended for washing of sperm and for sperm swim-up procedures. The medium can also be used for IUI (Intra Uterine Insemination).
Device Description
ARTSMedia Semen Wash Medium (AM Semen Wash) is intended for washing of sperm and for sperm swim-up procedures. The medium can also be used for IUI (Intra Uterine Insemination).
ARTSMedia Semen Wash Medium consists of physiological salts, energy substrates, buffering agents, Gentamicin Sulphate, and water.
Furthermore, ARTSMedia Semen Wash Medium is aseptically filtered and provided in a volume of 20 mL. 50 mL. and 100 mL in pre-sterilized glass bottles closed with Fluorotec-coated stoppers and aluminum caps. The ARTSMedia Semen Wash Medium is tested for pH, osmolality, endotoxin, sterility, and sperm toxicity before lot release. The device has a shelf-life of 18 months when stored at 2-8°C and is for single-use only.
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K Number
K241132Device Name
ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100)
Manufacturer
ARTSMedia Denmark ApS
Date Cleared
2024-12-18
(238 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
Product Code :
MQL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ARTSMedia Oocyte Aspiration Medium (AM-Oocyte Aspiration) is intended for retrieval of human oocytes by follicular aspiration or flushing. The medium can also be used for washing of oocytes.
Device Description
ARTSMedia Oocyte Aspiration Medium (AM Oocyte Aspiration) is intended for retrieval of human oocytes by follicular aspiration or flushing. The medium can also be used for washing of oocytes.
ARTSMedia Oocyte Aspiration Medium consists of physiological salts, energy substrates, buffering agents, Human Serum Albumin, Gentamicin Sulphate, and water.
Furthermore, ARTSMedia Oocyte Aspiration Medium is aseptically filtered and provided in a volume of 20 mL, 50 mL, and 100 mL in pre-sterilized glass bottles closed with Fluorotec-coated stoppers and aluminum caps. The ARTSMedia Oocyte Aspiration Medium is tested for pH, osmolality, embryotoxicity, endotoxin, and sterility, before lot release. The device has a shelf-life of 18 months when stored at 2-8°C and is for single-use only.
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K Number
K242968Device Name
Giftlife® Single-Step Medium Plus
Manufacturer
Gimbo Medical Technology Shenzhen Co., Ltd.
Date Cleared
2024-11-22
(57 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
Product Code :
MQL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Giftlife Single-Step Medium Plus is used for culture of embryos from fertilization to the blastocyst stage.
Device Description
Not Found
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K Number
K240176Device Name
V-VITFREEZE and V-VITWARM
Manufacturer
VITROMED GmbH
Date Cleared
2024-09-13
(234 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
Product Code :
MQL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
V-VITFREEZE is intended for use in the vitrification of oocytes (MI), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
V- VITWARM is intended for use in the thawing of vitrified of oocytes (MI), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
Device Description
V-VITFREEZE AND V-VITWARM 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.
V-VITFREEZE (2mL vials) 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.
V-VITWARM (4mL vials) 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), Diluent Solution (DS) and Washing Solution (WS).
The base medium for the vitrification and thawing media includes water, salts, buffering agents, minerals, chelating agents, energy substrates, amino acids, hydroxypropyl cellulose, polymeric substance, gentamicin, and phenol red. Cryoprotectants in the media include ethylene glycol, (7.5% in ES and 15% in VS), DMSO (7.5% in ES and 15% in VS), and trehalose in VS, TS, and DS.
The five solutions in the V-VITFREZE and V-VITWARM kit are aseptically filtered (storage vials sterilized by radiation) and provided in polypropylene vials with high density polyethylene screw caps. They have a shelf-life of 12 months when stored at 2-8℃. Media in the vials can be used for up to seven days after vial opening.
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