Monarch PSP Cleaning Wipes

Basic Information

• Brand Name: Monarch PSP Cleaning Wipes
• Primary DI: D678B89102
• Version / Model: B8910
• Company Name: AIR TECHNIQUES, INC.
• Labeler DUNS: 043835081
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-07-06
• Public Version: 3
• Public Version Date: 2019-06-07
• Public Version Status: Update
• Public Device Record Key: 01f97f95-7695-41bf-bb0a-0eb7d81dfbb4

Device Description

Lightweight disposable fabric wipes used to remove dust, hair, dirt and smudges from imaging surface.

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: Yes
• 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
IWZ	Film, Radiographic	Radiology	892.1840	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45171	Dry medical towel/wipe, single-use	A dry fabric intended to be used to wipe or dry a patient’s intact skin (not related to wound care), clean medical devices/equipment (e.g., endoscopes, ultrasound systems), and/or clean the general environment (e.g., fluid spill). It may be moistened (e.g., with water or used together with disinfectant/cleaning solutions) however no solutions are included. Some devices may be provided sterile, or designed to be sterilized, for use under sterile conditions [e.g., within an operating room (OR)]; devices intended for non-surgical applications may be provided and used in a non-sterile state. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D678B89102	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]