Catalog Number

MDSM3A7208058

Brand Name

Medline

Version/Model Number

MDSM3A7208058

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"

Yes

For Single-Use

Yes

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

K173113,K183431,K211931,K173113,K183431,K211931

Product Code

FLL

Product Code Name

Thermometer, electronic, clinical

Public Device Record Key

8e514548-3c17-425a-91d7-317c660ee96a

Public Version Date

April 25, 2022

Public Version Number

1

DI Record Publish Date

April 15, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-