AccessGUDID - DEVICE: GD (00862186000348)

GUDID

Device Identifier (DI) Information

Brand Name: GD
Version or Model: Prep-Check Plus, 37 pin
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EIM 107-37A
Company Name: General Devices

Primary DI Number: 00862186000348
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 101394815 *Terms of Use

Device Description: The Prep-Check Plus, 37 pin, is a hand-held, battery powered device intended to measure the electrical impedance of bio-potential electrodes applied to patients. It has 37 Lead EEG with 37 Pin Female "D" Connector (All 37 Pins Wired) .

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
GZO	Device, Galvanic Skin Response Measurement

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K993202	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7717cc63-d476-4a39-b51b-f68590262e16
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2016