Catalog Number

SO-1189-0

Brand Name

n/a

Version/Model Number

SO-1189-0

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

-

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

c888eb97-6d65-4abf-ae01-9e85947d160e

Public Version Date

August 05, 2022

Public Version Number

3

DI Record Publish Date

November 30, 2016

Package DI Number

10607411889100

Quantity per Package

50

Contains DI Package

00607411889103

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-