Catalog Number

NON66201

Brand Name

Medline

Version/Model Number

NON66201

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

K190502,K190502

Product Code

PNR

Product Code Name

Enteral Syringes with enteral specific connectors

Public Device Record Key

8d50c871-2aab-44c7-819d-24a4dfcaaafa

Public Version Date

October 29, 2021

Public Version Number

2

DI Record Publish Date

December 09, 2020

Package DI Number

20888277703664

Quantity per Package

500

Contains DI Package

10888277703667

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE