Catalog Number

684064

Brand Name

IN-LINE INJECTATE SENSOR CABLE-SP4046-1

Version/Model Number

684064

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

-

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

316cb84d-9e47-4593-b06d-c58de757fd86

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 25, 2016

Package DI Number

50886333640640

Quantity per Package

1

Contains DI Package

00886333640645

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Zip bag