Catalog Number

58210

Brand Name

pNeuton

Version/Model Number

58210

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

K925217,K925217

Product Code

CAH

Product Code Name

Filter, Bacterial, Breathing-Circuit

Public Device Record Key

18cfe39f-0822-4fec-8aea-a0c6f558513c

Public Version Date

February 06, 2020

Public Version Number

4

DI Record Publish Date

January 10, 2017

Package DI Number

00853678006689

Quantity per Package

50

Contains DI Package

00853678006672

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-