Catalog Number

-

Brand Name

Qingdao Bright

Version/Model Number

QGD-SU12-52*52

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

MLN

Product Code Name

Electrode, Electrocardiograph, Multi-Function

Public Device Record Key

cb1618f5-8897-48a8-b8d7-244b3c0dcaa3

Public Version Date

June 25, 2018

Public Version Number

1

DI Record Publish Date

May 23, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-