Catalog Number

-

Brand Name

Custom Medical Specialties, Inc.

Version/Model Number

CMS-108

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

BYY

Product Code Name

Tube, Aspirating, Flexible, Connecting

Public Device Record Key

2b58ca3a-bfb9-432c-8777-b055b113d296

Public Version Date

July 04, 2022

Public Version Number

3

DI Record Publish Date

December 07, 2016

Package DI Number

00815849021426

Quantity per Package

50

Contains DI Package

00815849021419

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-