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

Duns Number:002348191

Device Description: Pressure Injectable ARROWg+ard Blue Plus(R) Multi-Lumen Central Venous Catheterization Kit

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More Product Details

Catalog Number

ASK-45703-PSSM

Brand Name

ARROW

Version/Model Number

IPN036383

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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

127fd963-9a1b-4144-aedc-f083c3f67203

Public Version Date

February 19, 2021

Public Version Number

7

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

30801902109485

Quantity per Package

3

Contains DI Package

00801902109484

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