Catalog Number

C100020-10

Brand Name

Halyard

Version/Model Number

44282

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

K052117,K052117

Product Code

MEB

Product Code Name

PUMP, INFUSION, ELASTOMERIC

Public Device Record Key

89a53152-bea6-43ed-a2ba-bfbbe933568d

Public Version Date

November 16, 2018

Public Version Number

4

DI Record Publish Date

September 30, 2016

Package DI Number

30680651442827

Quantity per Package

10

Contains DI Package

10680651442823

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS