Catalog Number

PMP-16-100C-SU

Brand Name

AVANOS

Version/Model Number

PMP-16-100C-SU

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KNT

Product Code Name

Tubes, gastrointestinal (and accessories)

Public Device Record Key

b3b40c48-3baa-4e03-ba75-08c2813ca6b5

Public Version Date

August 18, 2020

Public Version Number

1

DI Record Publish Date

August 10, 2020

Package DI Number

10193493478764

Quantity per Package

20

Contains DI Package

00193493478767

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS