Catalog Number

-

Brand Name

S-CATH™ Esophageal Temperature Probe

Version/Model Number

CS-2001 (65cm Length)

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

K112376,K112376,K112376

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

53e566f8-5f3b-40b3-a3e8-63f2ac8b8608

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

30860237000218

Quantity per Package

10

Contains DI Package

10860237000214

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-