Catalog Number

312121

Brand Name

BiPAP

Version/Model Number

Disposable Proximal Pressure Line, 84 in

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

K982454

Product Code

MNT

Product Code Name

Ventilator, continuous, minimal ventilatory support, facility use

Public Device Record Key

73130658-f555-45b0-ab66-5f0158f9eab0

Public Version Date

October 24, 2022

Public Version Number

3

DI Record Publish Date

May 28, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-