Catalog Number

PS12506-N

Brand Name

AVANOS

Version/Model Number

45051

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K063530,K063530

Product Code

MEB

Product Code Name

Pump, infusion, elastomeric

Public Device Record Key

e3205438-af9a-4973-b5bb-10afa2419800

Public Version Date

June 17, 2020

Public Version Number

2

DI Record Publish Date

May 07, 2020

Package DI Number

10193494450516

Quantity per Package

5

Contains DI Package

00193494450519

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS