Catalog Number

70106.3538

Brand Name

AVALON ELITE

Version/Model Number

Avalon Elite BiCaval Dual Lumen Catheter

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

K081820

Product Code

DWF

Product Code Name

CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Public Device Record Key

601219ca-c526-437b-a0e6-463a1027d5ad

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 31, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-