Catalog Number

-

Brand Name

Yirdoc

Version/Model Number

NEB-P

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

-

Product Code

OGG

Product Code Name

Humidifier Nebulizer Kit

Public Device Record Key

bd8f8d15-a9d1-4b75-8ca7-ef4911120074

Public Version Date

June 30, 2020

Public Version Number

1

DI Record Publish Date

June 22, 2020

Package DI Number

16971331400320

Quantity per Package

60

Contains DI Package

06971331400316

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box