AccessGUDID - DEVICE: GD (00862186000317)

GUDID

Device Identifier (DI) Information

Brand Name: GD
Version or Model: Prep-Check 30Hz
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: EIM-105-30Hz
Company Name: General Devices

Primary DI Number: 00862186000317
Issuing Agency: GS1
Commercial Distribution End Date: January 01, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 101394815 *Terms of Use

Device Description: The Prep-Check 30Hz is a hand-held, battery powered device intended to measure the electrical impedance of bio-potential electrodes a applied to patients. Impedance readings are measured at 30 Hz.

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):	Yes
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?
35028	Electrocardiographic electrode tester	An instrument designed to measure the electrical impedance between the surface of external electrocardiography electrodes and the skin; it is also typically capable of measuring interference voltages that may be stored on electrodes (i.e., offset voltage) and/or detect faulty lead wires and cables. The device is mainly used to assess the ability of a set of surface (skin) electrodes to conduct bioelectric signals from the skin to the electrodes; it can also measure the impedance of the lead wires and cables from the electrodes to the measuring unit. It is intended to be used by a healthcare provider in a clinical setting.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KRC	Tester, Electrode, Surface, Electrocardiographic

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f57e3fc1-1dff-450f-8439-0d1b147c0b15
Public Version Date: November 21, 2024
Public Version Number: 4
DI Record Publish Date: September 23, 2016