Catalog Number

-

Brand Name

YUWELL Sleep Apnea Breathing Therapy Mask

Version/Model Number

YF-01 (S)

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"

-

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

K203347,K203347

Product Code

BZD

Product Code Name

Ventilator, Non-Continuous (Respirator)

Public Device Record Key

23389a45-01ac-4e13-ac21-b1c66f026287

Public Version Date

October 25, 2021

Public Version Number

1

DI Record Publish Date

October 15, 2021

Package DI Number

26922166510576

Quantity per Package

10

Contains DI Package

06922166510572

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-