Demax

Basic Information

• Brand Name: Demax
• Primary DI: 06943718223382
• Version / Model: DPBD62/OFF
• 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: 2024-10-25
• Public Version: 2
• Public Version Date: 2025-02-24
• Public Version Status: Update
• Public Device Record Key: f94b0ced-0d86-4fce-8e13-86755d6d5a4f

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: Yes
• 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
MAV	Syringe, Balloon Inflation	Cardiovascular	870.1650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17541	Catheter/overtube balloon inflator, single-use	A device designed to inflate and regulate the pressure of the balloon of a catheter, endoscopic overtube, or other invasive device (e.g., tamp, endomicroscopy probe), typically by injecting and aspirating fluid or air within the balloon, and to deflate the balloon during a medical procedure. It typically consists of a dedicated manual syringe/plunger or electronic mechanism for inflation/deflation, an analogue or digital gauge/screen for monitoring pressure, a locking mechanism, and a connecting tube. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	16943718223389	GS1		20	In Commercial Distribution
Primary	06943718223382	GS1

Premarket Submissions

Submission Number	Supplement Number
K140943	000