Catalog Number

-

Brand Name

Flow-Safe II+ BiLevel Disposable CPAP System

Version/Model Number

10-57404

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

1c80a93d-ebe2-48b4-80d5-d44d5bb0b000

Public Version Date

January 22, 2021

Public Version Number

1

DI Record Publish Date

January 14, 2021

Package DI Number

30641043574045

Quantity per Package

5

Contains DI Package

10641043574041

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-