Catalog Number

-

Brand Name

Chemosite

Version/Model Number

120010

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 11, 2016

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

K961856,K961856

Product Code

LJS

Product Code Name

Catheter,intravascular,therapeutic,long-term greater than 30 days

Public Device Record Key

5babcb8e-9d1d-4287-9a29-daf749bef1cb

Public Version Date

September 19, 2022

Public Version Number

4

DI Record Publish Date

August 28, 2015

Package DI Number

20884521099224

Quantity per Package

12

Contains DI Package

10884521099227

Package Discontinue Date

March 11, 2016

Package Status

Not in Commercial Distribution

Package Type

CASE