VICTOR - Dongguan SIMZO Electronic Technology Co., Ltd.

Duns Number:544332470

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More Product Details

Catalog Number

-

Brand Name

VICTOR

Version/Model Number

HW-F2

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K173048,K173048,K173048

Product Code Details

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Device Record Status

Public Device Record Key

5df28083-2ab5-4c35-ba43-3f2522f6be39

Public Version Date

December 04, 2020

Public Version Number

3

DI Record Publish Date

August 17, 2020

Additional Identifiers

Package DI Number

10810021178278

Quantity per Package

1

Contains DI Package

00810021178271

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"DONGGUAN SIMZO ELECTRONIC TECHNOLOGY CO., LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 25