ARROW - Pressure Injectable Three-Lumen PICC with 130 cm - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: Pressure Injectable Three-Lumen PICC with 130 cm Wire

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More Product Details

Catalog Number

PR-34063-HPSL

Brand Name

ARROW

Version/Model Number

IPN922925

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

LJS

Product Code Name

Catheter, intravascular, therapeutic, long-term greater than 30 days

Device Record Status

Public Device Record Key

96d78c09-3490-41f2-abce-3f0a6c10880c

Public Version Date

October 25, 2021

Public Version Number

1

DI Record Publish Date

October 15, 2021

Additional Identifiers

Package DI Number

20801902203285

Quantity per Package

5

Contains DI Package

10801902203288

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