3/8" Custom Pack w RF32 & HMOD 70000 - BEQ-HMOD 70000-USA Adult Quadrox iD, BEQ-RF32 - DATASCOPE CORP.

Duns Number:001660786

Device Description: BEQ-HMOD 70000-USA Adult Quadrox iD, BEQ-RF32 Rotaflow, CDI Sat Cell3/8" System 100, Gas F BEQ-HMOD 70000-USA Adult Quadrox iD, BEQ-RF32 Rotaflow, CDI Sat Cell3/8" System 100, Gas Filter

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More Product Details

Catalog Number

701053941R02

Brand Name

3/8" Custom Pack w RF32 & HMOD 70000

Version/Model Number

BEQ-TOP 9005

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 05, 2021

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

DWE

Product Code Name

Tubing, Pump, Cardiopulmonary Bypass

Device Record Status

Public Device Record Key

ae0edfb8-d90d-4715-bc59-b09736dac2a0

Public Version Date

November 08, 2021

Public Version Number

4

DI Record Publish Date

May 04, 2018

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