Catalog Number

-

Brand Name

Luna®

Version/Model Number

LG3500

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"

Yes

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

BZD

Product Code Name

Ventilator, Non-Continuous (Respirator)

Public Device Record Key

5ed051a1-1429-452e-926a-2a03d1706125

Public Version Date

September 05, 2022

Public Version Number

1

DI Record Publish Date

August 26, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-