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

Duns Number:002348191

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

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More Product Details

Catalog Number

CS-24703-E

Brand Name

ARROW

Version/Model Number

IPN030143

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

ed99610e-2752-4be4-bbaf-b48ed9f98285

Public Version Date

June 28, 2022

Public Version Number

5

DI Record Publish Date

October 03, 2018

Additional Identifiers

Package DI Number

10801902097214

Quantity per Package

5

Contains DI Package

20801902097211

Package Discontinue Date

June 27, 2022

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