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510(k) Data Aggregation
K Number
K232579Device Name
Twoplus Applicator
Manufacturer
Hannah Life Technologies Pte Ltd.
Date Cleared
2023-12-21
(118 days)
Product Code
QYZ
Regulation Number
884.6110Why did this record match?
Product Code :
QYZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The twoplus Applicator is indicated for over-the-counter home use by individuals who choose not to conceive through intercourse. The twoplus Applicator kit allows for semen collection and the vaginal canal. The twoplus Applicator should be used during the ovulatory phase of the menstrual cycle.
Device Description
Not Found
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K Number
K231645Device Name
PherDal® At-Home Insemination Kit
Manufacturer
PherDal Fertility Science, Inc.
Date Cleared
2023-12-14
(192 days)
Product Code
QYZ
Regulation Number
884.6110Why did this record match?
Product Code :
QYZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PherDal® At-Home Insemination Kit is indicated for over-the-counter home use, by individuals who have been unable to conceive through intercourse or have chosen not to conceive through intercourse, for semen collection and the delivery of semen to the vaginal canal. The PherDal® At-Home Insemination Kit should be used during the ovulatory phase of the menstrual cycle.
Device Description
The PherDal® At-Home Insemination Kit is a sterile, over-the-counter (OTC) medical device intended for intravaginal insemination (IVI) at home. It consists of three sets of sterile, single-use, plastic syringes and semen collection cups, and Instructions for Use. The collection cup is used to hold and contain the sperm and work in conjunction with the syringe when it is time to transfer the syringe. The syringe is used to withdraw the semen from the collection cup and deploy the semen intravaginally.
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K Number
K231203Device Name
Mosie Baby Kit
Manufacturer
Mosie Baby
Date Cleared
2023-11-29
(216 days)
Product Code
QYZ, OYZ
Regulation Number
884.6110Why did this record match?
Product Code :
QYZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Mosie Baby Kit is indicated for over-the-counter home use, by individuals who have been unable to conceive through intercourse or choose not to conceive through intercourse, for semen collection and the delivery of semen or donor sperm to the vaginal canal. The Mosie Baby Kit should be used during the ovulatory phase of the menstrual cycle.
Device Description
The Mosie Baby Kit is an over-the-counter (OTC) device intended for intravaginal insemination (IVI) at home. The Mosie Baby Kit includes the following components:
- Two Mosie syringes
- Two Mosie collection cups
- Instructions for Use.
Each component is single-use only and supplied non-sterile. The collection cup is used to hold and contain the sperm and work in conjunction with the syringe when it is time to transfer the sperm into the syringe. The syringe is used to withdraw the semen from the collection cup and deploy the semen intravaginally. The syringe features a rounded front end with a slotted tip opening. The syringe has a rounded stopper that fits within the rounded end of the syringe to aid in sperm delivery from the syringe to the vagina. The syringe also contains flanges designed to aid in device handling during use.
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