ARROW - Two-Lumen Central Venous Catheterization Kit with - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter For Femoral Vei Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter For Femoral Vein Insertion

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More Product Details

Catalog Number

AK-16402

Brand Name

ARROW

Version/Model Number

IPN037177

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

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K862056,K862056,K862056

Product Code Details

Product Code

DQY

Product Code Name

Catheter, percutaneous

Device Record Status

Public Device Record Key

e229d109-f37e-43ff-b406-d9faf4c7e5e0

Public Version Date

February 19, 2021

Public Version Number

6

DI Record Publish Date

March 04, 2019

Additional Identifiers

Package DI Number

20801902122180

Quantity per Package

5

Contains DI Package

30801902122187

Package Discontinue Date

-

Package Status

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