Catalog Number

-

Brand Name

Chemosite

Version/Model Number

120026

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 11, 2016

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K952748

Product Code

LJT

Product Code Name

PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Public Device Record Key

e6195b53-9fc6-4eda-bdc7-b711eb2ade2a

Public Version Date

May 20, 2021

Public Version Number

5

DI Record Publish Date

August 28, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-