Catalog Number

-

Brand Name

SoWeCare

Version/Model Number

LX-26E

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K160816

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

0e55f6cd-0d66-4d76-9fc9-65140230f117

Public Version Date

December 04, 2020

Public Version Number

2

DI Record Publish Date

June 16, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-