Catalog Number

PB-30-1

Brand Name

QuickScan Pads

Version/Model Number

PB-30

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K123399,K123399

Product Code

HCC

Product Code Name

Device, Biofeedback

Public Device Record Key

28d2e04b-6c07-4b45-8332-7d9d16758772

Public Version Date

October 22, 2018

Public Version Number

4

DI Record Publish Date

December 07, 2016

Package DI Number

00853818007163

Quantity per Package

4

Contains DI Package

00853818007156

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Pack