Time-lapse Incubator Capacity Expansion Module

Basic Information

• Brand Name: Time-lapse Incubator Capacity Expansion Module
• Primary DI: 06975183900192
• Version / Model: TL-16EX
• 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: fbde40ac-8b9c-44be-9fb2-12cebfc4163d

Device Description

The Time-lapse Incubator can be connected to the capacity expansion module which in turn can also accommodate 16 culture dishes. The capacity expansion module is similar to the main incubator and provides the same culture capacity as the incubator host. However, it cannot be run independently and needs to be used together with the Incubator host

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	06975183900192	GS1

Premarket Submissions

Submission Number	Supplement Number
K242684	000

Device Sizes

Type	Value	Unit	Text
Weight	60	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