twoplus Applicator

Basic Information

• Brand Name: twoplus Applicator
• Primary DI: 08881300389024
• Version / Model: HC01
• Company Name: HANNAH LIFE TECHNOLOGIES PTE. LTD.
• Labeler DUNS: 659561833
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-02-06
• Public Version: 1
• Public Version Date: 2024-02-14
• Public Version Status: New
• Public Device Record Key: b74d03d9-55df-4a88-aa1d-5a9ae619fbf8

Device Description

An at home intravaginal insemination system to deliver semen to the vaginal canal for insemination.

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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QYZ	At Home Intravaginal Insemination System	Obstetrics/Gynecology	884.6110	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64137	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08881300389024	GS1

Premarket Submissions

Submission Number	Supplement Number
K232579	000