AccessGUDID - DEVICE: PC Electrometer Reference Class Dual-Channel Electrometer (BNC) (B01610140000Z0)

GUDID

Device Identifier (DI) Information

Brand Name: PC Electrometer Reference Class Dual-Channel Electrometer (BNC)
Version or Model: 10140000Z
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 10140000Z
Company Name: SUN NUCLEAR CORP.

Primary DI Number: B01610140000Z0
Issuing Agency: HIBCC
Commercial Distribution End Date: March 19, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 122240021 *Terms of Use

Device Description: Radiation therapy QA device.

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):	Yes
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?
36596	Radiation electrometer	A stand-alone external measuring device with a detection circuit that can be used with different ion chamber probes for conducting dosimetry measurements in high radiation fields. An electrometer typically includes output read out capabilities in charge, current, time, dose and dose rate.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IYE	Accelerator, Linear, Medical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K092019	000

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
Special Storage Condition, Specify: Store the instrument in an indoor, protected environment where it will not be irradiated by the direct beam and where scattered radiation will be kept at a minimum.
Special Storage Condition, Specify: Before storage, install caps on both detector inputs. The input connector interior has high impedance; the caps protect the inputs from contamination which could cause increased leakage current.
Handling Environment Atmospheric Pressure: between 18.7 and 106 KiloPascal
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between -30 and 50 Degrees Celsius
Storage Environment Atmospheric Pressure: between 57.2 and 106 KiloPascal
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between 10 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ad59f4c2-953b-4470-a7e1-ff38489579a8
Public Version Date: March 19, 2019
Public Version Number: 5
DI Record Publish Date: January 14, 2017