Catalog Number

H93853300

Brand Name

AVANOS

Version/Model Number

H93853300

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)

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

b8d24c6a-c0b7-4062-9d2c-4c23648dcabe

Public Version Date

May 21, 2021

Public Version Number

1

DI Record Publish Date

May 13, 2021

Package DI Number

10350770003105

Quantity per Package

4

Contains DI Package

00350770003108

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

DSP