Catalog Number

-

Brand Name

Patient Loading and Utility System (PLUS)

Version/Model Number

PL660-019-13

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

CAN

Product Code Name

Regulator, Pressure, Gas Cylinder

Public Device Record Key

590de539-b42d-47f1-b83a-d3a62af3d0a1

Public Version Date

November 12, 2021

Public Version Number

1

DI Record Publish Date

November 04, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-