Home GUDID 00860011225126
PherDal At-Home Insemination Kit
Primary DI 00860011225126
Brand PherDal At-Home Insemination Kit
Company PHERDAL FERTILITY SCIENCE, INC.
Model PherDal
Device description The PherDal ® At-Home Insemination Kit is for individuals who desire to self-inseminate. It consists of 3 sets of disposable, sterile, plastic syringes and semen collection cups with snap-on lids.
Published 2026-07-06
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC true
Sterile true
Single use true
Product Codes# Code, Name table Code Name QYZ At Home Intravaginal Insemination System
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QYZ At Home Intravaginal Insemination System Obstetrics/Gynecology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00860011225126 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00860011225126 00860011225126 860011225126 0860011225126
GMDN Terms# Term, Definition table Term Definition Home-use artificial insemination kit A collection of devices intended to be used in the home for self or assisted intracervical insemination in order to promote conception. It includes containers for semen collection, tips for semen transfer into syringes, and syringes for the transfer of semen into the female reproductive tract. This is a single-use device.
Sterilization Methods# Method table Method Radiation Sterilization
Regulatory Flags# DUNS number 119129993 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit true Combination product false Lot or batch false Serial number false Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use true Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 08881300389024 twoplus Applicator HANNAH LIFE TECHNOLOGIES PTE. LTD. QYZ 2024-02-06