Catalog Number

-

Brand Name

Custom Medical Specialties, Inc.

Version/Model Number

CMS-6479-R1

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

K993463,K993463

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

0f42e44d-0599-4105-9553-31a36d25792b

Public Version Date

July 19, 2021

Public Version Number

4

DI Record Publish Date

September 11, 2018

Package DI Number

00815849023192

Quantity per Package

25

Contains DI Package

00815849023185

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-