CLEARLINK/CONTINU-FLO - CONTINU-FLO Solution Set, 2 Luer Activated - BAXTER INTERNATIONAL INC.

Duns Number:005146311

Device Description: CONTINU-FLO Solution Set, 2 Luer Activated Valves, Male Luer Lock Adapter, 3-Port Manifold CONTINU-FLO Solution Set, 2 Luer Activated Valves, Male Luer Lock Adapter, 3-Port Manifold with Check Valves, Large Bore Stopcock Extension Set with Rotating Male Luer Lock, 2 Luer Activated Valves, Male Luer Lock Adapter with Retractable Collar

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More Product Details

Catalog Number

2C8931

Brand Name

CLEARLINK/CONTINU-FLO

Version/Model Number

2C8931

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

K932512,K932512

Product Code Details

Product Code

FMG

Product Code Name

Stopcock, i.V. Set

Device Record Status

Public Device Record Key

0c94cb67-c67b-46ba-b1d6-53323994ccca

Public Version Date

April 07, 2021

Public Version Number

5

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

50085412071720

Quantity per Package

48

Contains DI Package

00085412071725

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