Catalog Number

-

Brand Name

RLV-T Suction Control Device

Version/Model Number

4103105

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

-

Product Code

DWD

Product Code Name

Suction Control, Intracardiac, Cardiopulmonary Bypass

Public Device Record Key

5aaa84db-cfb2-45d0-9a0f-c7ac90bfec91

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 29, 2017

Package DI Number

20634624431052

Quantity per Package

50

Contains DI Package

00634624431058

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper