EMSRUN

Basic Information

• Brand Name: EMSRUN
• Primary DI: 06974567745213
• Version / Model: PZZX0002
• Company Name: Wuxi Emsrun Technology Co., Ltd.
• Labeler DUNS: 542972552
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-02
• Public Version: 1
• Public Version Date: 2022-12-12
• Public Version Status: New
• Public Device Record Key: c425e413-c8a3-4bf9-a7be-3363dd8fbc2d

Device Characteristics

• Single Use: Yes
• 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: Yes
• 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
CAN	Regulator, Pressure, Gas Cylinder	Anesthesiology	868.2700	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41132	Helium/oxygen refillable cylinder	A container designed as a refillable cylinder used to hold a compressed mixture of 79% helium (He) and 21% oxygen (O2) under safe conditions at high pressure (e.g., 50 - 150 Bar). It is typically filled with He/O2 when delivered from the gas supplier and includes a valve stem, an opening/closing valve, and will be graded according to size (capacity) and colour-coded to denote He/O2 content. The cylinder is typically made of steel, aluminium (Al) or other non-ferrous materials and must be used together with a pressure regulator in order to release the He/O2 at the correct working pressure. He/O2 is used as a breathing gas; being three times less dense than air, it is easier to breathe.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06974567745213	GS1