Catalog Number

ONQFT

Brand Name

Halyard

Version/Model Number

47645

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

Product Code

MEB

Product Code Name

Pump, Infusion, Elastomeric

Public Device Record Key

aaa6e386-2cde-4be8-9edd-7bebb0284393

Public Version Date

September 18, 2020

Public Version Number

2

DI Record Publish Date

January 03, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-