Catalog Number

ONEL027-01

Brand Name

Halyard

Version/Model Number

ONEL027-01_0006

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

NNI

Product Code Name

CONTAINER, SPECIMEN, NON-STERILE

Public Device Record Key

315875bd-942d-4a74-9433-333eb3261114

Public Version Date

October 29, 2021

Public Version Number

2

DI Record Publish Date

December 11, 2020

Package DI Number

20809160321093

Quantity per Package

100

Contains DI Package

10809160321096

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-