ARROW - Two-Lumen Hemodialysis Catheterization Set with - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: Two-Lumen Hemodialysis Catheterization Set with Blue FlexTip (R) Catheter for High Volume Two-Lumen Hemodialysis Catheterization Set with Blue FlexTip (R) Catheter for High Volume Infusions

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More Product Details

Catalog Number

CS-12122-E

Brand Name

ARROW

Version/Model Number

IPN030060

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

K991431,K991431

Product Code Details

Product Code

MPB

Product Code Name

CATHETER, HEMODIALYSIS, NON-IMPLANTED

Device Record Status

Public Device Record Key

316585f9-d264-4e60-bb18-351a4d17a338

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

October 16, 2015

Additional Identifiers

Package DI Number

30801902100093

Quantity per Package

5

Contains DI Package

00801902100092

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