ARROW - Epidural Catheterization Kit with FlexTip - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: Epidural Catheterization Kit with FlexTip Plus(R), Closed Tip Multi-Port Catheter

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More Product Details

Catalog Number

MP-17019-TK

Brand Name

ARROW

Version/Model Number

IPN046495

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

K140110,K140110

Product Code Details

Product Code

BSO

Product Code Name

CATHETER, CONDUCTION, ANESTHETIC

Device Record Status

Public Device Record Key

b589429b-1d54-410d-a816-d9a529e224e8

Public Version Date

February 07, 2019

Public Version Number

7

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

30801902070198

Quantity per Package

5

Contains DI Package

00801902070197

Package Discontinue Date

July 20, 2018

Package Status

Not in Commercial Distribution

Package Type

Box

"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