Catalog Number

120012

Brand Name

Chemosite

Version/Model Number

120012

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

K952748,K952748

Product Code

LJT

Product Code Name

PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Public Device Record Key

24d706ed-cbcc-4d1a-a681-1782caa23b0b

Public Version Date

October 23, 2019

Public Version Number

4

DI Record Publish Date

August 28, 2015

Package DI Number

20884521099163

Quantity per Package

20

Contains DI Package

10884521099166

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE