Catalog Number

-

Brand Name

SuperFlow Tubing Set

Version/Model Number

21512

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"

-

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

K981286,K981286

Product Code

KDH

Product Code Name

Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration

Public Device Record Key

5a81e971-172d-4fe9-a1ff-0f0bbb269387

Public Version Date

April 23, 2019

Public Version Number

5

DI Record Publish Date

August 29, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-