Catalog Number

-

Brand Name

Custom Medical Specialties

Version/Model Number

CMS-963

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

BYX

Product Code Name

Tubing, Pressure And Accessories

Public Device Record Key

74eacbf9-0361-4acc-bf3a-bdfaefbc7791

Public Version Date

July 04, 2022

Public Version Number

3

DI Record Publish Date

March 06, 2017

Package DI Number

00815849023055

Quantity per Package

10

Contains DI Package

00815849023048

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-