ARROW - Central Venous Catheterization Kit - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: Central Venous Catheterization Kit

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More Product Details

Catalog Number

AK-04225

Brand Name

ARROW

Version/Model Number

IPN033854

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

K781978,K781978

Product Code Details

Product Code

FMF

Product Code Name

Syringe, piston

Device Record Status

Public Device Record Key

96c78369-a59d-42d9-967f-41cd60589ce7

Public Version Date

February 19, 2021

Public Version Number

5

DI Record Publish Date

December 01, 2017

Additional Identifiers

Package DI Number

20801902004943

Quantity per Package

10

Contains DI Package

10801902004946

Package Discontinue Date

March 08, 2018

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