Hy-GeneTM Seminal Fluid Collection Kit

Basic Information

• Brand Name: Hy-GeneTM Seminal Fluid Collection Kit
• Primary DI: 00862242000305
• Version / Model: ACK-121
• Catalog Number: ACK-121
• Company Name: APEX MEDICAL TECHNOLOGIES, INC.
• Labeler DUNS: 154115885
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-09-05
• Public Version: 2
• Public Version Date: 2026-01-14
• Public Version Status: Update
• Public Device Record Key: e7c79606-6e84-4aa7-ba71-abb95e86f85b

Device Description

Specimen Collection Container for the collection of semen.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HIS	Condom	Obstetrics/Gynecology	884.5300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63772	Semen specimen collection container	A sterile, covered, plastic receptacle intended to be used for the collection, preservation, and/or transport of a semen specimen intended for diagnostic and/or therapeutic use including, but not limited to, semen analysis, intrauterine insemination, in vitro fertilization (IVF), and/or intracytoplasmic sperm injection (ICSI). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00862242000312	GS1	Box	30	In Commercial Distribution
Primary	00862242000305	GS1
Package	00862242000329	GS1	Box	100	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K954791	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 38 Degrees Celsius