Catalog Number

1221

Brand Name

Halyard

Version/Model Number

93881

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

12badaca-a5f0-4357-a719-befc0f27bc2a

Public Version Date

April 20, 2020

Public Version Number

2

DI Record Publish Date

January 01, 2019

Package DI Number

30609038000344

Quantity per Package

50

Contains DI Package

10609038000340

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS