Catalog Number

QUE400

Brand Name

Aero-Med

Version/Model Number

QUE400

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

JRC

Product Code Name

MICRO PIPETTE

Public Device Record Key

d028616c-63f0-4555-8ed8-c6a9fe568579

Public Version Date

April 04, 2019

Public Version Number

1

DI Record Publish Date

March 27, 2019

Package DI Number

50810011100034

Quantity per Package

20

Contains DI Package

10810011100036

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE