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

Contact Domains#

Product Codes#

Code, Name table
CodeName
QYZAt Home Intravaginal Insemination System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QYZAt Home Intravaginal Insemination SystemObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231645000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231645000PherDal® At-Home Insemination KitPherdal Fertility Science, Inc.2023-12-14QYZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860011225126PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860011225126008600112251268600112251260860011225126

GMDN Terms#

Term, Definition table
TermDefinition
Home-use artificial insemination kitA 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

Contacts#

Phone, Email table
PhoneEmail
872-216-8330support@pherdal.com

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 DIBrandCompanyProduct codePublished
08881300389024twoplus ApplicatorHANNAH LIFE TECHNOLOGIES PTE. LTD.QYZ2024-02-06