Catalog Number

SO-1145

Brand Name

n/a

Version/Model Number

SO-1145

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

-

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

6a01ddb8-ae9c-4c57-a5e3-6c4741bf776b

Public Version Date

August 05, 2022

Public Version Number

3

DI Record Publish Date

November 30, 2016

Package DI Number

10607411940436

Quantity per Package

100

Contains DI Package

00607411940439

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-