Catalog Number

-

Brand Name

KBMED

Version/Model Number

ES3

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K182649,K182649

Product Code

PNR

Product Code Name

Enteral Syringes With Enteral Specific Connectors

Public Device Record Key

697101ca-e64a-445e-bbc3-4304af746910

Public Version Date

October 29, 2021

Public Version Number

2

DI Record Publish Date

November 18, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-