Catalog Number

-

Brand Name

Custom Medical Specialties, Inc.

Version/Model Number

CMS-1214

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

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

2447fe78-8683-4b32-b28e-6cca5aae5f8b

Public Version Date

April 07, 2021

Public Version Number

4

DI Record Publish Date

December 07, 2016

Package DI Number

00815849021136

Quantity per Package

25

Contains DI Package

00815849021129

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-