NOKIA - SCT01 is the device for the measurement of body - YA HORNG ELECTRONIC CO., LTD.

Duns Number:656103819

Device Description: SCT01 is the device for the measurement of body temperature.

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More Product Details

Catalog Number

-

Brand Name

NOKIA

Version/Model Number

SCT01

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Device Record Status

Public Device Record Key

10f226a8-8ef2-41ac-aed5-237d88091604

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 10, 2017

Additional Identifiers

Package DI Number

14719873310064

Quantity per Package

6

Contains DI Package

04719873310067

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"YA HORNG ELECTRONIC 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. 4