AccessGUDID - DEVICE: QuickScan Pads & Electrodes Pack (00853818007255)

GUDID

Device Identifier (DI) Information

Brand Name: QuickScan Pads & Electrodes Pack
Version or Model: PB-35
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PRECISION BIOMETRICS INC

Primary DI Number: 00853818007255
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 362997926 *Terms of Use

Device Description: 3 pack of Single Jar pads, 00853818007156 3 packs of 10ea static electrodes (PB-212), 00853818007231 1 Medical Tweezer, 00853818007170

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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
11425	Electrode conductive medium	A non-sterile substance intended to be used as a medium for the efficient transmission of electrical signals between an electrode and the body, and for the reduction of the isolation properties of the skin. It is typically in the form of a gel, paste, spray or cream and is usually used in electrocardiography, defibrillation and diathermy. After application, this device cannot be reused.	Active	false
35035	Electrocardiographic electrode, single-use	A non-sterile, noninvasive electrical conductor designed to conduct electrical signals, generated by a patient's heart, from the skin surface to an electrocardiograph (ECG) monitoring device, via an ECG lead wire (not included). It is typically a disk-like electrode that is affixed to the skin with a special adhesive, adhesive tape, or suction mechanism; a conductive gel may be pre-applied and it may include a skin cleaning wipe to assist electrical connection. Electrocardiography is usually performed using a set of electrodes (e.g., 10) connected to appropriate leads and cables. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KQX	Goniometer, Ac-Powered
HCS	Device, Temperature Measurement, Direct Contact, Powered
HCC	Device, Biofeedback
IKN	Electromyograph, Diagnostic

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: 126f20b8-699a-45ec-b9be-fe9b221027d1
Public Version Date: October 22, 2018
Public Version Number: 3
DI Record Publish Date: December 13, 2016