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More Product Details

Catalog Number

-

Brand Name

Equate

Version/Model Number

EQ-HW-EC-250-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

-

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

5b9985ca-e236-4e44-b2a6-6355bb6e34a4

Public Version Date

May 04, 2020

Public Version Number

1

DI Record Publish Date

April 24, 2020

Additional Identifiers

Package DI Number

16947468554809

Quantity per Package

1

Contains DI Package

06947468554802

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

10pcs/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