Catalog Number

SPX3100S19

Brand Name

BiPAP

Version/Model Number

SPX3100S19

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

-

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

K121623

Product Code

MNT

Product Code Name

Ventilator, continuous, minimal ventilatory support, facility use

Public Device Record Key

beea871c-d943-4e4d-9013-7486830328a2

Public Version Date

December 23, 2020

Public Version Number

1

DI Record Publish Date

December 15, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-