INTERLINK - Extension Set, Injection Site, Male Luer Lock - BAXTER INTERNATIONAL INC.

Duns Number:005146311

Device Description: Extension Set, Injection Site, Male Luer Lock Adapter with Retractable Collar

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

2C6605

Brand Name

INTERLINK

Version/Model Number

2C6605

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 30, 2020

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

K961225,K961225

Product Code Details

Product Code

FPA

Product Code Name

Set, administration, intravascular

Device Record Status

Public Device Record Key

c7109e2e-97eb-40fc-9972-f0dd05ed75a6

Public Version Date

June 30, 2020

Public Version Number

5

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

50085412002335

Quantity per Package

48

Contains DI Package

00085412002330

Package Discontinue Date

June 30, 2020

Package Status

Not 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