Demax

Basic Information

• Brand Name: Demax
• Primary DI: 06943718225201
• Version / Model: DHD1024
• Company Name: Beijing Demax Medical Technology Co., Ltd.
• Labeler DUNS: 529725666
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-01-11
• Public Version: 1
• Public Version Date: 2023-01-19
• Public Version Status: New
• Public Device Record Key: 9846b5a7-f797-47d7-8ac2-91df290f2a10

Device Characteristics

• Single Use: Yes
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
DXC	Clamp, Vascular	Cardiovascular	870.4450	2

GMDN Terms

Code	Name	Definition	Implantable	Status
10234	Rotating pneumatic tourniquet system	An automatic-cycling device assembly designed to prevent blood flow in one limb at a time, temporarily reducing the total blood flow volume with the intention of reducing the normal workload of the heart. It typically consists of a pneumatic tourniquet cuff, a source of gas pressure used to regularly inflate the cuff, and an automatic control unit, i.e., a pressure indicator and regulator. By using a double cuff and automated valves the pressure point is regularly changed to avoid tissue damage or necrosis.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	16943718225208	GS1		50	In Commercial Distribution
Primary	06943718225201	GS1

Premarket Submissions

Submission Number	Supplement Number
K222182	000