Catalog Number

-

Brand Name

Mon-a-Therm

Version/Model Number

90045

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

K875234,K875234,K875234

Product Code

FLL

Product Code Name

Thermometer, electronic, clinical

Public Device Record Key

2865cd0b-25cd-451a-8290-517fb593b11a

Public Version Date

October 21, 2022

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

20884521031576

Quantity per Package

50

Contains DI Package

30884521031573

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK_OR_INNER_PACK