Harioculture TL-16 Time-lapse Incubator

Basic Information

• Brand Name: Harioculture TL-16 Time-lapse Incubator
• Primary DI: 06975183900185
• Version / Model: Harioculture TL-16
• Company Name: Hua Yue Medical Technology Co., Ltd.
• Labeler DUNS: 625413598
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-09-30
• Public Version: 1
• Public Version Date: 2025-10-08
• Public Version Status: New
• Public Device Record Key: 08c971e0-e22b-4ee5-bcf0-85ec7465120d

Device Description

Time-lapse Incubator provides an environment with controlled temperature and gas concentrations (CO2 and O2) or mixed gas (CO2 and other gases) for the development of embryos at or near body temperature. Use of the Time-lapse Incubator is limited to five days (120 hr) covering the time from post insemination to day five of development.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• 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: Yes
• Has Lot/Batch Number: No
• 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
MQG	Accessory, Assisted Reproduction	Obstetrics/Gynecology	884.6120	2
MQK	Labware, Assisted Reproduction	Obstetrics/Gynecology	884.6160	2
MTX	Microscope And Microscope Accessories, Reproduction, Assisted	Obstetrics/Gynecology	884.6190	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61195	Assisted reproduction incubator/microscope camera system	An assembly of mains electricity (AC-powered) devices intended to be used during assisted reproduction/in vitro fertilization (IVF) to incubate reproductive biological materials (e.g., gametes and embryos) at closely regulated and monitored temperatures, whilst acquiring, processing, and storing images of the embryo cultures, over the course of development, to assist embryo selection. It consists of an incubator with a built-in digital microscope still camera, monitor, and software; it may include additional supportive devices (e.g., printer). The system may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentrations].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06975183900185	GS1

Premarket Submissions

Submission Number	Supplement Number
K242684	000

Device Sizes

Type	Value	Unit	Text
Weight	65	Kilogram

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: – 85 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 18 – 30 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 5 – 80 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -10 – 40 Degrees Celsius