Catalog Number

20002

Brand Name

pNeuton

Version/Model Number

S

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

-

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

Product Code

CBK

Product Code Name

Ventilator, Continuous, Facility Use

Public Device Record Key

0a0e49e3-7cee-4247-bb27-898579f08585

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 23, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-