Catalog Number

M041228-0

Brand Name

N/A

Version/Model Number

M041228-0

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)

Yes

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

be3848fd-d0d7-47e5-b0da-6cf3e0ea311b

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 16, 2016

Package DI Number

10607411302821

Quantity per Package

25

Contains DI Package

00607411302824

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-