Catalog Number

DEX2900S13

Brand Name

BiPAP

Version/Model Number

BiPAP A30 EFL, DE

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

5ca7b168-f152-4e9b-a561-13286028b72d

Public Version Date

April 26, 2021

Public Version Number

2

DI Record Publish Date

March 19, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-