Catalog Number

-

Brand Name

Flow-Safe II Disposable CPAP System

Version/Model Number

10-57217

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2019

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

3b307756-8b15-46f9-a0e9-d441607a44e8

Public Version Date

December 31, 2019

Public Version Number

5

DI Record Publish Date

September 24, 2015

Package DI Number

30641043572171

Quantity per Package

5

Contains DI Package

10641043572177

Package Discontinue Date

December 31, 2019

Package Status

Not in Commercial Distribution

Package Type

-