Catalog Number

PM028-A-N

Brand Name

Halyard

Version/Model Number

44937

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

0bd39684-9d0f-4b8f-b1f2-080b1801ba37

Public Version Date

November 16, 2018

Public Version Number

4

DI Record Publish Date

August 02, 2017

Package DI Number

30680651449376

Quantity per Package

5

Contains DI Package

10680651449372

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS