Catalog Number

8001-063-414

Brand Name

8001 Series Foley Catheter Temperature Probe

Version/Model Number

8001-063-414

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

2bb85a38-48dd-4afe-9874-056a308e961d

Public Version Date

September 18, 2018

Public Version Number

3

DI Record Publish Date

July 01, 2016

Package DI Number

H29780010634142

Quantity per Package

10

Contains DI Package

H29780010634141

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer Box