Cook - Connecting Tube Female to Male Luer Lock - COOK INCORPORATED

Duns Number:042823948

Device Description: Connecting Tube Female to Male Luer Lock

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More Product Details

Catalog Number

DPT9.5-240-P-FM

Brand Name

Cook

Version/Model Number

G00042

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"

-

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

DTL

Product Code Name

Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass

Device Record Status

Public Device Record Key

2cf926a4-7eae-4213-a60a-d3a9dae2bae7

Public Version Date

July 28, 2020

Public Version Number

4

DI Record Publish Date

August 22, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"COOK INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 669
2 A medical device with a moderate to high risk that requires special controls. 8328
3 A medical device with high risk that requires premarket approval 370
U Unclassified 242