AccessGUDID - DEVICE: NA (08800019200000)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: EPX-F1600
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ECO-ER-CAT-001P
Company Name: ECOTRON

Primary DI Number: 08800019200000
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 688209954 *Terms of Use

Device Description: Input Power: 110V~120V, 50/60Hz Output Power: 1.6kW KVP range: 40~90kV mA range: 12~30mA mAs range: 0.4~32mAs X-ray Tube: D-125 Focal Sport: 1.2 x 1.2mm Target Angle: 16 degrees Anode heat storage: 50kHU

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
37606	Diagnostic x-ray system generator, portable	An x-ray generator with special size, weight, and power requirements that makes it suitable for use in a portable x-ray system, e.g., a system intended to be easily disassembled and reassembled at various locations. It is used to regulate incoming voltage and current in order to provide an x-ray tube with the power needed to produce an x-ray beam of the desired voltage (kV) and current (mA). This GMDN code includes transformer and inverter generator designs. Portable x-ray generators typically comprise a control assembly (console) and high voltage transformer assembly or are of a mono-tank generator design.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IZL	System, X-Ray, Mobile

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -25 and 60 Degrees Celsius
Handling Environment Humidity: between 35 and 75 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Width: 200 Millimeter
Height: 190 Millimeter
Length: 355 Millimeter
Weight: 13 Kilogram

Device Record Status

Public Device Record Key: 99bcab4b-24eb-4a79-866a-66c97d360efb
Public Version Date: November 16, 2020
Public Version Number: 4
DI Record Publish Date: September 28, 2016