ARROW - Pressure Injectable Arrowg+ard Blue Plus(R) - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: Pressure Injectable Arrowg+ard Blue Plus(R) Three-Lumen CVC

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

CDC-45703-XP1A

Brand Name

ARROW

Version/Model Number

IPN036437

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

K071538,K071538

Product Code Details

Product Code

FOZ

Product Code Name

Catheter,intravascular,therapeutic,short-term less than 30 days

Device Record Status

Public Device Record Key

4668319e-75f8-440a-95ea-a4cf683ad40d

Public Version Date

June 14, 2022

Public Version Number

9

DI Record Publish Date

September 11, 2017

Additional Identifiers

Package DI Number

30801902117213

Quantity per Package

5

Contains DI Package

20801902117216

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