Catalog Number

MC061422MB

Brand Name

SLX Hemo-Cath®

Version/Model Number

MC061422MB

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

045f4ce3-f0f3-4117-bf69-25cdc578c49d

Public Version Date

March 28, 2022

Public Version Number

1

DI Record Publish Date

March 18, 2022

Package DI Number

50884908163815

Quantity per Package

4

Contains DI Package

00884908163810

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box