Catalog Number

-

Brand Name

Qingyuan

Version/Model Number

QY-EWQ-02

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K201536,K201536,K201536

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

fd280ae6-9278-43d9-8653-e048f051e3a1

Public Version Date

March 12, 2021

Public Version Number

1

DI Record Publish Date

March 04, 2021

Package DI Number

16973150480453

Quantity per Package

1

Contains DI Package

06973150480456

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX