Catalog Number

-

Brand Name

SLX Hemo-Cath®

Version/Model Number

MC061425

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 24, 2020

Issuing Agency

In GS1

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

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

LFJ

Product Code Name

CATHETER, SUBCLAVIAN

Public Device Record Key

04a42874-905e-40bd-b02d-c2e8fb8e1a1a

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

October 23, 2015

Package DI Number

50884908083342

Quantity per Package

5

Contains DI Package

00884908083347

Package Discontinue Date

June 24, 2020

Package Status

Not in Commercial Distribution

Package Type

box