Catalog Number

-

Brand Name

MicroAire®

Version/Model Number

ASP-CAN-2S

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 04, 2022

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

K150779

Product Code

KDQ

Product Code Name

Bottle, Collection, Vacuum

Public Device Record Key

b94542bd-8498-4ba4-b062-882610698317

Public Version Date

June 06, 2022

Public Version Number

3

DI Record Publish Date

January 13, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-