Vent Line - DATASCOPE CORP.

Duns Number:001660786

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More Product Details

Catalog Number

701062807

Brand Name

Vent Line

Version/Model Number

BO-T 30902

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

DWE

Product Code Name

Tubing, Pump, Cardiopulmonary Bypass

Device Record Status

Public Device Record Key

5ac945a3-3c25-4ce5-96de-ec5b61d764b5

Public Version Date

January 28, 2019

Public Version Number

5

DI Record Publish Date

March 28, 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