AccessGUDID - DEVICE: Sapyen At-Home Male Fertility Analysis Kit (09309000599004)

GUDID

Device Identifier (DI) Information

Brand Name: Sapyen At-Home Male Fertility Analysis Kit
Version or Model: 1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1
Company Name: VITO HEALTH PTY LTD

Primary DI Number: 09309000599004
Issuing Agency: GS1
Commercial Distribution End Date: January 01, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 750355719 *Terms of Use

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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
66354	Home semen collection kit IVD	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KDT	Container, Specimen Mailer And Storage, Sterile

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store between 2 and 8 degrees celsius prior to use.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b94b1444-0690-449b-9798-05f1dee05459
Public Version Date: January 01, 2024
Public Version Number: 2
DI Record Publish Date: April 13, 2023