EMSRUN

Basic Information

• Brand Name: EMSRUN
• Primary DI: 06974567742625
• Version / Model: PZDF0001
• 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: c86b92a1-5044-4da7-8618-1f98c8d869b8

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: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: High Intensity Light or Pulse Light

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LRJ	Disinfectant, Medical Devices	General Hospital	880.6890	1

GMDN Terms

Code	Name	Definition	Implantable	Status
40744	Radiation prep-pad warmer	A mains electricity (AC-powered) device designed to heat factory-sealed prep pads (skin cleansing pads typically containing alcohol or povidone iodine), with a pre-set maximum temperature (e.g., 55?C) for the purpose of warming the pads prior to use on a paediatric patient, notably to reduce the number of venous access attempts (needle sticks). The device is typically of tabletop design and includes a heat exchanger that uses electromagnetic radiation (e.g., radio-frequency, microwaves) to transmit heat to the packaged pads that have been placed in separate compartments within the device; it also includes temperature controls and/or alarms.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06974567742625	GS1