IIF - intended to measure human body temperature - HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO.,LTD.

Duns Number:544611767

Device Description: intended to measure human body temperature

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More Product Details

Catalog Number

-

Brand Name

IIF

Version/Model Number

DT-111B

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

-

Product Code Details

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Device Record Status

Public Device Record Key

f8bf708c-4f59-4f94-a75a-1dd3905d2881

Public Version Date

January 18, 2022

Public Version Number

1

DI Record Publish Date

January 10, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS 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. 20