NA - Large Bore Stopcock with Rotating Male Luer Lock - BAXTER INTERNATIONAL INC.

Duns Number:005146311

Device Description: Large Bore Stopcock with Rotating Male Luer Lock

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More Product Details

Catalog Number

2C6204

Brand Name

NA

Version/Model Number

2C6204

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

K130245,K130245

Product Code Details

Product Code

FMG

Product Code Name

Stopcock, i.V. Set

Device Record Status

Public Device Record Key

c4c5c780-ccea-47a0-8327-8c8ae6442c91

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

50085412001918

Quantity per Package

50

Contains DI Package

00085412001913

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"BAXTER INTERNATIONAL INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 358