ARROW - 15 Fr. x 50 cm Edge(R) Hemodialysis Catheter(.) - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: 15 Fr. x 50 cm Edge(R) Hemodialysis Catheter(.) Long-Term Access. Catheter Length, Tip to 15 Fr. x 50 cm Edge(R) Hemodialysis Catheter(.) Long-Term Access. Catheter Length, Tip to Cuff: 50 cm

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More Product Details

Catalog Number

AC-15502-ICO

Brand Name

ARROW

Version/Model Number

IPN032584

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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

K111117,K111117,K111117

Product Code Details

Product Code

MSD

Product Code Name

Catheter, hemodialysis, implanted

Device Record Status

Public Device Record Key

004d5fb0-8147-4e45-b5b9-d21cac4fba67

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

October 16, 2015

Additional Identifiers

Package DI Number

30801902096037

Quantity per Package

1

Contains DI Package

10801902096033

Package Discontinue Date

January 10, 2019

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