ARROW - Arrowg+ard Blue(R) One-Lumen CVC - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: Arrowg+ard Blue(R) One-Lumen CVC

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More Product Details

Catalog Number

CA-24301

Brand Name

ARROW

Version/Model Number

IPN914881

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

K900263,K900263

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

fa92077f-ceec-4013-b8dc-630f11f132ff

Public Version Date

January 28, 2022

Public Version Number

5

DI Record Publish Date

April 24, 2020

Additional Identifiers

Package DI Number

30801902159039

Quantity per Package

10

Contains DI Package

40801902159036

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