ECOMAX

Basic Information

• Brand Name: ECOMAX
• Primary DI: 04260502640012
• Version / Model: 1186
• Catalog Number: 1186-3-4000
• Company Name: PROTEC GmbH & Co. KG
• Labeler DUNS: 314629130
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-28
• Public Version: 3
• Public Version Date: 2019-12-17
• Public Version Status: Update
• Public Device Record Key: b3240e8d-e266-4550-b11a-eed7868e0a32
• Distribution End Date: 2019-12-16

Device Description

Darkroom automated x-ray film processor

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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
IXW	Processor, Radiographic-Film, Automatic	Radiology	892.1900	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41011	Darkroom automated x-ray film processor	A mains electricity (AC-powered) automated darkroom film processing device in which x-ray/radiographic film must be manually removed from a cassette and loaded into the processor in a darkroom setting. It is designed to transport x-ray or radiographic film from one solution to the next in the developing process without any manual labour except the insertion of the film. It has typically six main sub-systems: transport, temperature, circulation, replenishment, drying and electrical control.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04260502640012	GS1

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 50 – 80 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 18 – 40 Degrees Celsius