Catalog Number

CB003B-N

Brand Name

Halyard

Version/Model Number

47059

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

K181360,K181360

Product Code

MEB

Product Code Name

PUMP, INFUSION, ELASTOMERIC

Public Device Record Key

bad0c6af-c03f-4e67-923e-b384c27323c4

Public Version Date

May 13, 2019

Public Version Number

1

DI Record Publish Date

May 04, 2019

Package DI Number

30680651470592

Quantity per Package

5

Contains DI Package

10680651470598

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS