Catalog Number

CIV-031

Brand Name

CIV

Version/Model Number

CIV-031

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 03, 2020

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"

Yes

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

K935642,K935642

Product Code

FPK

Product Code Name

Tubing, Fluid Delivery

Public Device Record Key

db771619-df6c-4661-b978-bbb01871647c

Public Version Date

April 07, 2021

Public Version Number

7

DI Record Publish Date

September 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-