Catalog Number

-

Brand Name

InnoSpire Deluxe

Version/Model Number

1112278

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

2dd9ba56-26a8-4bcf-9888-f892a00c744f

Public Version Date

July 02, 2018

Public Version Number

1

DI Record Publish Date

June 01, 2018

Package DI Number

16946159502013

Quantity per Package

6

Contains DI Package

06946159502016

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-