3/8 to 1/4" Taperflex Tubing - DATASCOPE CORP.

Duns Number:001660786

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More Product Details

Catalog Number

709000298

Brand Name

3/8 to 1/4" Taperflex Tubing

Version/Model Number

BEQ-T 44501

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

b967a10b-9fb3-4176-b43e-23473b4e8b8f

Public Version Date

December 02, 2019

Public Version Number

4

DI Record Publish Date

August 16, 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