Catalog Number

C465-3208

Brand Name

Coeur Acist

Version/Model Number

C465-3208

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K063114,K063114,K063114

Product Code

FPK

Product Code Name

Tubing, Fluid Delivery

Public Device Record Key

4be0f855-5d57-4a35-88c9-009632bfb904

Public Version Date

February 04, 2019

Public Version Number

3

DI Record Publish Date

July 14, 2016

Package DI Number

M297632086

Quantity per Package

100

Contains DI Package

M297632080

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

shipper