Catalog Number

-

Brand Name

Able Central Venous Catheter Double Lumen 8F*13cm

Version/Model Number

02L-FV-2824

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K070451,K070451,K070451

Product Code

FOZ

Product Code Name

Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days

Public Device Record Key

2b7f33e8-3cb0-4ce4-856b-be2bdcde76ff

Public Version Date

February 19, 2021

Public Version Number

5

DI Record Publish Date

September 20, 2016

Package DI Number

26938634490271

Quantity per Package

40

Contains DI Package

06938634490277

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-