Catalog Number

-

Brand Name

Rite Aid Pharmacy

Version/Model Number

LUL535

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KFZ

Product Code Name

Humidifier, Non-Direct Patient Interface (Home-Use)

Public Device Record Key

6d9fd0e8-fe87-4d32-8804-617b2d46b058

Public Version Date

May 29, 2020

Public Version Number

1

DI Record Publish Date

May 21, 2020

Package DI Number

10328785004790

Quantity per Package

2

Contains DI Package

00011822781947

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE