Promethean

Basic Information

• Brand Name: Promethean
• Primary DI: B325PI44001
• Version / Model: Island 4400
• Catalog Number: PI4400
• Company Name: M D Technologies Inc.
• Labeler DUNS: 859679045
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 8
• Record Status: Published
• Publish Date: 2022-08-05
• Public Version: 2
• Public Version Date: 2025-07-31
• Public Version Status: Update
• Public Device Record Key: 500e7a9c-041c-4ab8-849a-997259996756
• Distribution End Date: 2025-07-31

Device Description

Fluid Collecting Floor Mat for Collection, Measurement and Disposal of Surgical Fluids. Case of 8.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• 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
FLH	Washer Of Body Waste Receptacles	General Hospital	880.6800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61850	Absorbent underpad, non-antimicrobial, single-use	A flat piece of absorbent fabric material [e.g., non-woven polyethylene (PE), cellulose] intended to be placed on a surface (e.g., bed mattress, table, floor) and underneath a patient to absorb bodily fluids resulting from surgical procedures, childbirth and/or incontinence; it does not include an antimicrobial agent(s). It is intended to be used in the healthcare facility and in the home. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	B325PI44000	HIBCC
Primary	B325PI44001	HIBCC

Customer Contacts

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