Catalog Number

-

Brand Name

LUNA PAQ®

Version/Model Number

LU3001

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

-

Product Code Name

-

Public Device Record Key

9da9af73-afbc-4576-8c9b-d982f78a64a5

Public Version Date

June 17, 2022

Public Version Number

5

DI Record Publish Date

September 23, 2016

Package DI Number

20858701006241

Quantity per Package

6

Contains DI Package

10858701006244

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box