ONE-LINK - Non-DEHP Standard Bore Catheter Extension Set, - BAXTER INTERNATIONAL INC.

Duns Number:005146311

Device Description: Non-DEHP Standard Bore Catheter Extension Set, Bonded Needle-free IV Connector with Neutra Non-DEHP Standard Bore Catheter Extension Set, Bonded Needle-free IV Connector with Neutral Fluid Displacement, Power Injectable, Male Luer Lock Adapter with Retractable Collar

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More Product Details

Catalog Number

7N8391

Brand Name

ONE-LINK

Version/Model Number

7N8391

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

K132734,K132734

Product Code Details

Product Code

FPA

Product Code Name

Set, administration, intravascular

Device Record Status

Public Device Record Key

8dacdf8e-3f1f-4eca-afef-3adae3671c86

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

50085412475405

Quantity per Package

200

Contains DI Package

00085412475400

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