Catalog Number

-

Brand Name

Suction tip

Version/Model Number

SU-xxxxx

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

K982891,K982891

Product Code

DTS

Product Code Name

SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS

Public Device Record Key

bd7dae47-660e-4e44-8ef2-d45a88f25c11

Public Version Date

April 20, 2020

Public Version Number

6

DI Record Publish Date

July 16, 2015

Package DI Number

10803622105880

Quantity per Package

10

Contains DI Package

00803622105883

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE