Catalog Number

99789-01

Brand Name

Halyard

Version/Model Number

99789

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

-

Product Code

JOL

Product Code Name

CATHETER AND TIP, SUCTION

Public Device Record Key

b624d1d1-04cc-461a-866d-a8074eb67e25

Public Version Date

November 16, 2018

Public Version Number

3

DI Record Publish Date

March 15, 2017

Package DI Number

20680651997894

Quantity per Package

10

Contains DI Package

10680651997897

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

dsp