Catalog Number

-

Brand Name

Flow-Safe II+ BiLevel Disposable CPAP System

Version/Model Number

10-57403

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

K090710,K090710

Product Code

BYE

Product Code Name

Attachment, Breathing, Positive End Expiratory Pressure

Public Device Record Key

af920a2f-341c-44da-920a-730e5a63adc9

Public Version Date

May 20, 2020

Public Version Number

3

DI Record Publish Date

May 31, 2018

Package DI Number

30641043574038

Quantity per Package

5

Contains DI Package

10641043574034

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-