Catalog Number

QUE710

Brand Name

Aero-Med

Version/Model Number

QUE710

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

GAA

Product Code Name

NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Public Device Record Key

531d1f53-7222-4a3d-ab2e-2e7cfe672ce8

Public Version Date

June 17, 2022

Public Version Number

3

DI Record Publish Date

March 27, 2019

Package DI Number

50810010892077

Quantity per Package

10

Contains DI Package

10810010892079

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE