MDHC

Basic Information

• Brand Name: MDHC
• Primary DI: 06974669350322
• Version / Model: 5 pcs/bag
• Company Name: MDHC Life Technologies (Kunshan) Co., LTD.
• Labeler DUNS: 625685749
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-06
• Public Version: 1
• Public Version Date: 2023-07-14
• Public Version Status: New
• Public Device Record Key: ff8c46be-1ca6-44e9-9efe-e7f97e37ed43

Device Description

Cooling Box

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MXT	Device, Accessory, Cooling Plate For Tissue Embedding Station	Pathology	864.3010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60309	Heater/cooler system tester kit	A collection of devices intended to be used to test/calibrate a clinical heater/cooler system (e.g., extravascular-circulation hyperthermia system, heating/cooling pad systems) with respect to fluid flow, thermal calibration, and electronic integrity. The kit may include a pressure/flow calibration unit, a thermocouple thermometer, a breakout box and relevant connection cables. It is intended to be used by a healthcare provider (i.e., clinical technician) in a clinical setting.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06974669350322	GS1