Catalog Number

189A000

Brand Name

AVANOS

Version/Model Number

189A000

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

K941562,K941562

Product Code

FMF

Product Code Name

Syringe, piston

Public Device Record Key

2f67f3ef-0bd8-416b-8128-e790cb1b07fd

Public Version Date

August 26, 2020

Public Version Number

2

DI Record Publish Date

September 25, 2019

Package DI Number

10193493985866

Quantity per Package

25

Contains DI Package

00193493985869

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS