Catalog Number

-

Brand Name

Custom Medical Specialties, Inc.

Version/Model Number

CMS-142

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GCE

Product Code Name

Adaptor, Catheter

Public Device Record Key

a8157483-212e-4f61-9413-d47636215e08

Public Version Date

August 09, 2018

Public Version Number

3

DI Record Publish Date

November 30, 2017

Package DI Number

00815849023147

Quantity per Package

50

Contains DI Package

00815849023130

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-