Catalog Number

-

Brand Name

Patient Loading and Utility System (PLUS)

Version/Model Number

P6601-01-090

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

BTI

Product Code Name

Compressor, Air, Portable

Public Device Record Key

ac1b541d-1abd-43a9-a9e5-b273b655edb0

Public Version Date

July 14, 2020

Public Version Number

1

DI Record Publish Date

July 06, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-