Catalog Number

H93889005

Brand Name

AVANOS

Version/Model Number

H93889005

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

PNR

Product Code Name

Enteral Syringes with enteral specific connectors

Public Device Record Key

b38f525a-33c0-4c2d-9d2b-6798d461cb15

Public Version Date

October 29, 2021

Public Version Number

2

DI Record Publish Date

May 13, 2021

Package DI Number

10350770001576

Quantity per Package

200

Contains DI Package

00350770001579

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS