Catalog Number

58001

Brand Name

pNeuton

Version/Model Number

58001

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

K024344,K024344

Product Code

CBK

Product Code Name

Ventilator, Continuous, Facility Use

Public Device Record Key

62980a52-d472-4e22-9abd-ad32c7a2dfce

Public Version Date

October 24, 2022

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

00853678006061

Quantity per Package

15

Contains DI Package

00853678006054

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box