Quick Temp Infrared Thermometer - Infrared Thermometer - HOME AIDE DIAGNOSTICS, INC.

Duns Number:783518983

Device Description: Infrared Thermometer

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More Product Details

Catalog Number

-

Brand Name

Quick Temp Infrared Thermometer

Version/Model Number

CK-T1501

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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

K193253,K193253

Product Code Details

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Device Record Status

Public Device Record Key

77b055ad-76d2-48e3-aacc-41e17c270c78

Public Version Date

August 10, 2020

Public Version Number

1

DI Record Publish Date

July 31, 2020

Additional Identifiers

Package DI Number

10850632007598

Quantity per Package

50

Contains DI Package

00850632007591

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer Carton

"HOME AIDE DIAGNOSTICS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 24
2 A medical device with a moderate to high risk that requires special controls. 44
U Unclassified 11