Catalog Number

861556

Brand Name

MEAS 4400 Series Temperature Probe

Version/Model Number

4466

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Product Code

EZL

Product Code Name

Catheter, Retention Type, Balloon

Public Device Record Key

03966035-5107-4e6a-a993-fd0f34736fab

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 01, 2016

Package DI Number

H29744661

Quantity per Package

10

Contains DI Package

H29744660

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case