Catalog Number

189A030

Brand Name

AVANOS

Version/Model Number

189A030

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

BSP

Product Code Name

NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Public Device Record Key

b4a28211-2541-47c4-9774-bef341a9b04a

Public Version Date

December 13, 2021

Public Version Number

3

DI Record Publish Date

September 25, 2019

Package DI Number

10193493985910

Quantity per Package

25

Contains DI Package

00193493985913

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS