Catalog Number

970008

Brand Name

Halyard

Version/Model Number

45255

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

-

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

1b526ae2-cfe6-497c-9c16-696518557351

Public Version Date

November 16, 2018

Public Version Number

3

DI Record Publish Date

July 14, 2017

Package DI Number

30680651452550

Quantity per Package

16

Contains DI Package

20680651452553

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS