Catalog Number

PS12505-A-N

Brand Name

AVANOS

Version/Model Number

45098

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

055cfb31-832f-43d6-b693-9bc74306dc45

Public Version Date

June 16, 2020

Public Version Number

1

DI Record Publish Date

June 08, 2020

Package DI Number

10193494450981

Quantity per Package

5

Contains DI Package

00193494450984

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS