ARROW - Arterial Catheterization Kit - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: Arterial Catheterization Kit

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More Product Details

Catalog Number

ASK-04020-SHUF

Brand Name

ARROW

Version/Model Number

IPN056190

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

K810675,K810675,K810675

Product Code Details

Product Code

DQX

Product Code Name

Wire, guide, catheter

Device Record Status

Public Device Record Key

ef56d5c7-3391-4f0b-9bb3-64c21c28a86e

Public Version Date

September 17, 2021

Public Version Number

2

DI Record Publish Date

March 26, 2021

Additional Identifiers

Package DI Number

40801902160711

Quantity per Package

5

Contains DI Package

30801902160714

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