Catalog Number

-

Brand Name

COVERS,TEMP PROBE

Version/Model Number

M09A-20-62124

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K170712,K170712,K170712,K170712

Product Code

MWI

Product Code Name

Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Public Device Record Key

b41f0e47-58ce-4b07-bb8b-b72754e7b175

Public Version Date

November 10, 2021

Public Version Number

3

DI Record Publish Date

April 29, 2020

Package DI Number

06944904031330

Quantity per Package

10

Contains DI Package

06944904007892

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-