Sapyen At-Home Male Fertility Analysis Kit

Primary DI
09309000599004
Brand
Sapyen At-Home Male Fertility Analysis Kit
Company
VITO HEALTH PTY LTD
Model
1
Catalog number
1
Device description
Sapyen At-Home Male Fertility Analysis Kit - At-home male fertility diagnostic kit, which enables customers to collect semen samples from the comfort of their own home without having to rush out the door to drop their sample to the nearest testing centre. Our kit extends the shelf life of sperm, so customers can send their sample via normal postal services to accredited labs for semen analysis. After the analysis, customers receive a comprehensive report explaining the results on each of their parameters and providing recommendations that consider their health history.
Published
2023-04-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KDTContainer, Specimen Mailer And Storage, Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDTContainer, Specimen Mailer And Storage, SterilePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09309000599004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09309000599004093090005990049309000599004

GMDN Terms#

Term, Definition table
TermDefinition
Home semen collection kit IVDA collection of in vitro diagnostic devices and materials intended to be used by a layperson in the home to collect a semen specimen for subsequent in vitro diagnostic investigations (e.g., fertility testing). The kit typically includes a covered specimen receptacle with a preservative, a pipette, instructions for use, and/or a return packing/envelope for submission/mailing to the clinical laboratory. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store between 2 and 8 degrees celsius prior to use.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
750355719
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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