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More Product Details

Catalog Number

-

Brand Name

Bytech

Version/Model Number

EQ-HW-TH-150-DI

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

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

K140681,K140681,K140681

Product Code Details

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Device Record Status

Public Device Record Key

0bb45cc6-2343-4309-b249-15a72e093ca8

Public Version Date

January 01, 2020

Public Version Number

1

DI Record Publish Date

December 24, 2019

Additional Identifiers

Package DI Number

26947468554707

Quantity per Package

12

Contains DI Package

16947468554700

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

12pcs/box

"SHENZHEN BELTER HEALTH MEASUREMENT AND ANALYSIS 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