Catalog Number

-

Brand Name

Custom Medical Specialties, Inc.

Version/Model Number

ERRORCMS-155

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

6d2a94bc-c13a-42af-9550-7ca9385982cb

Public Version Date

April 07, 2021

Public Version Number

3

DI Record Publish Date

November 27, 2018

Package DI Number

00815849023222

Quantity per Package

100

Contains DI Package

00815849023208

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-