ARROW - Arrow Endurance(TM) Extended Dwell Peripheral - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: Arrow Endurance(TM) Extended Dwell Peripheral Catheter System

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More Product Details

Catalog Number

ASK-00622-MSH

Brand Name

ARROW

Version/Model Number

IPN926640

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

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

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

6b0555e1-c435-4965-8286-4551d7d2bbd6

Public Version Date

September 13, 2022

Public Version Number

1

DI Record Publish Date

September 05, 2022

Additional Identifiers

Package DI Number

20801902212119

Quantity per Package

5

Contains DI Package

10801902212112

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