Wyltec - Infrared Ear Thermometer - 3J'S HEALTHCARE GROUP LLC

Duns Number:080425823

Device Description: Infrared Ear Thermometer

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More Product Details

Catalog Number

-

Brand Name

Wyltec

Version/Model Number

W01-0201

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

6336c2c5-4c3f-4c2c-8d8d-1e05aaaf5c91

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

May 22, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"3J'S HEALTHCARE GROUP LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 14