Catalog Number

-

Brand Name

Mon-a-Therm

Version/Model Number

90044

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

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K874514,K874514,K874514

Product Code

FLL

Product Code Name

Thermometer, electronic, clinical

Public Device Record Key

531c5fe4-b6e0-493f-a6df-e3c967826eeb

Public Version Date

August 03, 2021

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

30884521031597

Quantity per Package

50

Contains DI Package

20884521031590

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK_OR_INNER_PACK