Catalog Number

SO-2084

Brand Name

N/A

Version/Model Number

SO-2084

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

5a70b179-9b93-4c6a-8f73-44d4db17f430

Public Version Date

August 05, 2022

Public Version Number

2

DI Record Publish Date

March 30, 2018

Package DI Number

10607411961035

Quantity per Package

50

Contains DI Package

00607411961038

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-