Catalog Number

CA-0001-001

Brand Name

Inline Sensor Assembly and Inline Temperature Sensor

Version/Model Number

INLINE TEMPERATURE SENSOR (ILS-1)

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 01, 2020

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

-

Product Code

DQO

Product Code Name

Catheter, Intravascular, Diagnostic

Public Device Record Key

66670dc4-65a6-49be-ad66-46ecf3dc88ef

Public Version Date

March 10, 2021

Public Version Number

7

DI Record Publish Date

September 01, 2016

Package DI Number

98888893019515

Quantity per Package

50

Contains DI Package

08888893019512

Package Discontinue Date

December 01, 2020

Package Status

Not in Commercial Distribution

Package Type

PULK PACK