Sapyen At-Home Male Fertility Analysis Kit 1

GUDID 09309000599004

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.

VITO HEALTH PTY LTD

Home semen collection kit IVD
Primary Device ID09309000599004
NIH Device Record Keyb94b1444-0690-449b-9798-05f1dee05459
Commercial Distribution Discontinuation2024-01-01
Commercial Distribution StatusIn Commercial Distribution
Brand NameSapyen At-Home Male Fertility Analysis Kit
Version Model Number1
Catalog Number1
Company DUNS750355719
Company NameVITO HEALTH PTY LTD
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store between 2 and 8 degrees celsius prior to use.
Special Storage Condition, SpecifyBetween 0 and 0 *Store between 2 and 8 degrees celsius prior to use.
Special Storage Condition, SpecifyBetween 0 and 0 *Store between 2 and 8 degrees celsius prior to use.
Special Storage Condition, SpecifyBetween 0 and 0 *Store between 2 and 8 degrees celsius prior to use.
Special Storage Condition, SpecifyBetween 0 and 0 *Store between 2 and 8 degrees celsius prior to use.
Special Storage Condition, SpecifyBetween 0 and 0 *Store between 2 and 8 degrees celsius prior to use.
Special Storage Condition, SpecifyBetween 0 and 0 *Store between 2 and 8 degrees celsius prior to use.
Special Storage Condition, SpecifyBetween 0 and 0 *Store between 2 and 8 degrees celsius prior to use.
Special Storage Condition, SpecifyBetween 0 and 0 *Store between 2 and 8 degrees celsius prior to use.
Special Storage Condition, SpecifyBetween 0 and 0 *Store between 2 and 8 degrees celsius prior to use.
Special Storage Condition, SpecifyBetween 0 and 0 *Store between 2 and 8 degrees celsius prior to use.
Special Storage Condition, SpecifyBetween 0 and 0 *Store between 2 and 8 degrees celsius prior to use.
Special Storage Condition, SpecifyBetween 0 and 0 *Store between 2 and 8 degrees celsius prior to use.
Special Storage Condition, SpecifyBetween 0 and 0 *Store between 2 and 8 degrees celsius prior to use.
Special Storage Condition, SpecifyBetween 0 and 0 *Store between 2 and 8 degrees celsius prior to use.
Special Storage Condition, SpecifyBetween 0 and 0 *Store between 2 and 8 degrees celsius prior to use.
Special Storage Condition, SpecifyBetween 0 and 0 *Store between 2 and 8 degrees celsius prior to use.
Special Storage Condition, SpecifyBetween 0 and 0 *Store between 2 and 8 degrees celsius prior to use.
Special Storage Condition, SpecifyBetween 0 and 0 *Store between 2 and 8 degrees celsius prior to use.
Special Storage Condition, SpecifyBetween 0 and 0 *Store between 2 and 8 degrees celsius prior to use.
Special Storage Condition, SpecifyBetween 0 and 0 *Store between 2 and 8 degrees celsius prior to use.
Special Storage Condition, SpecifyBetween 0 and 0 *Store between 2 and 8 degrees celsius prior to use.
Special Storage Condition, SpecifyBetween 0 and 0 *Store between 2 and 8 degrees celsius prior to use.
Special Storage Condition, SpecifyBetween 0 and 0 *Store between 2 and 8 degrees celsius prior to use.
Special Storage Condition, SpecifyBetween 0 and 0 *Store between 2 and 8 degrees celsius prior to use.
Special Storage Condition, SpecifyBetween 0 and 0 *Store between 2 and 8 degrees celsius prior to use.
Special Storage Condition, SpecifyBetween 0 and 0 *Store between 2 and 8 degrees celsius prior to use.
Special Storage Condition, SpecifyBetween 0 and 0 *Store between 2 and 8 degrees celsius prior to use.
Special Storage Condition, SpecifyBetween 0 and 0 *Store between 2 and 8 degrees celsius prior to use.
Special Storage Condition, SpecifyBetween 0 and 0 *Store between 2 and 8 degrees celsius prior to use.
Special Storage Condition, SpecifyBetween 0 and 0 *Store between 2 and 8 degrees celsius prior to use.
Special Storage Condition, SpecifyBetween 0 and 0 *Store between 2 and 8 degrees celsius prior to use.
Special Storage Condition, SpecifyBetween 0 and 0 *Store between 2 and 8 degrees celsius prior to use.
Special Storage Condition, SpecifyBetween 0 and 0 *Store between 2 and 8 degrees celsius prior to use.
Special Storage Condition, SpecifyBetween 0 and 0 *Store between 2 and 8 degrees celsius prior to use.

Device Identifiers

Device Issuing AgencyDevice ID
GS109309000599004 [Primary]

FDA Product Code

KDTContainer, Specimen Mailer And Storage, Sterile

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-04-21
Device Publish Date2023-04-13
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