Catalog Number

-

Brand Name

Custom Medical Specialties, Inc.

Version/Model Number

CMS-1228-NS

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

GAZ

Product Code Name

Tubing, Noninvasive

Public Device Record Key

97c322e7-8d71-4622-86b3-68d65bb7f5ec

Public Version Date

February 19, 2021

Public Version Number

2

DI Record Publish Date

August 18, 2020

Package DI Number

00815849023338

Quantity per Package

25

Contains DI Package

00815849023321

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-