1/4" Specialty Pack - BEQ-HMOD 70000-USA Adult Quadrox iD,Softshell - DATASCOPE CORP.

Duns Number:001660786

Device Description: BEQ-HMOD 70000-USA Adult Quadrox iD,Softshell Venous Reser. 800ml,BEQ-RF32 RotaFlow,CDI Sa BEQ-HMOD 70000-USA Adult Quadrox iD,Softshell Venous Reser. 800ml,BEQ-RF32 RotaFlow,CDI Sat Cell 1/4" System 100,Blood Microfilter System SQ 40 S,Prebypass filter w/o Vent Porous Media 3/8x3/8,Gas Filter.

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More Product Details

Catalog Number

701056549R01

Brand Name

1/4" Specialty Pack

Version/Model Number

BEQ-TOP 39100

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 22, 2019

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

f5ebd69b-fb55-4209-8dda-c36d4a25f857

Public Version Date

February 22, 2019

Public Version Number

4

DI Record Publish Date

March 09, 2017

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