Catalog Number

DS2N030-65

Brand Name

CPS AIM™

Version/Model Number

Universal

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

DQY

Product Code Name

CATHETER, PERCUTANEOUS

Public Device Record Key

b1e0990c-c75b-4d7d-968b-567ca83db7ff

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

March 23, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-