ARROW - 4 Fr. Catheter Clamp with Fastener - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: 4 Fr. Catheter Clamp with Fastener

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More Product Details

Catalog Number

CC-00004

Brand Name

ARROW

Version/Model Number

IPN032953

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

KGZ

Product Code Name

ACCESSORIES, CATHETER

Device Record Status

Public Device Record Key

102e4828-d11f-4abf-8fd3-7e62b348e91a

Public Version Date

March 16, 2020

Public Version Number

6

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

30801902007941

Quantity per Package

25

Contains DI Package

00801902007940

Package Discontinue Date

March 12, 2020

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