ARROW - Large-Bore Multi-Lumen Central Venous - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: Large-Bore Multi-Lumen Central Venous Catheterization Set with Blue FlexTip(R) Catheter fo Large-Bore Multi-Lumen Central Venous Catheterization Set with Blue FlexTip(R) Catheter for High Volume Infusions

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More Product Details

Catalog Number

CS-16123-F

Brand Name

ARROW

Version/Model Number

IPN037616

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

K862056,K862056

Product Code Details

Product Code

DQY

Product Code Name

Catheter, percutaneous

Device Record Status

Public Device Record Key

5f34df0f-0d63-4932-b0c8-a4706874fe90

Public Version Date

August 15, 2022

Public Version Number

5

DI Record Publish Date

October 17, 2019

Additional Identifiers

Package DI Number

80801902129259

Quantity per Package

5

Contains DI Package

30801902129254

Package Discontinue Date

August 12, 2022

Package Status

Not in Commercial Distribution

Package Type

Case

"TELEFLEX INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3195
2 A medical device with a moderate to high risk that requires special controls. 13747
3 A medical device with high risk that requires premarket approval 3
U Unclassified 26