Catalog Number

-

Brand Name

MicroAire®

Version/Model Number

SR-51-083

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 30, 2021

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

HTR

Product Code Name

Rasp

Public Device Record Key

35d40fcb-04be-42f6-bad9-f1086c299074

Public Version Date

January 06, 2022

Public Version Number

1

DI Record Publish Date

December 29, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-