Small Adult Open Heart Pack - HMO 51000 (BO coated) Quadrox i Small Adult with - DATASCOPE CORP.

Duns Number:001660786

Device Description: HMO 51000 (BO coated) Quadrox i Small Adult with integral filter,BO-VHK 71000 Venous Reser HMO 51000 (BO coated) Quadrox i Small Adult with integral filter,BO-VHK 71000 Venous Reservoir,Blood Transfer Bag 1000 ml - 2 spike ports,BO-RF32 RotaFlow,BC 60 plus,CDI Sat Cell 3/8" System 100,Prebypass filter w/o Vent Porous Media 3/8x1/2,Gas Filter

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More Product Details

Catalog Number

709000168

Brand Name

Small Adult Open Heart Pack

Version/Model Number

BO-TOP 40013

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 20, 2018

Issuing Agency

In GS1

Product Characteristics

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

-

Product Code Details

Product Code

DWF

Product Code Name

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Device Record Status

Public Device Record Key

5ce376ee-5a93-4da5-ab84-8ee43ffcdb5e

Public Version Date

January 28, 2019

Public Version Number

5

DI Record Publish Date

December 15, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DATASCOPE CORP." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 663