Catalog Number

P400X4D-N

Brand Name

AVANOS

Version/Model Number

44935

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

-

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

K063530,K063530

Product Code

MEB

Product Code Name

Pump, infusion, elastomeric

Public Device Record Key

20dc35ef-e989-470b-b6e4-8dab8886203a

Public Version Date

May 15, 2020

Public Version Number

1

DI Record Publish Date

May 07, 2020

Package DI Number

10193494449350

Quantity per Package

5

Contains DI Package

00193494449353

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS