Catalog Number

CA5450

Brand Name

Aero-Med

Version/Model Number

CA5450

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

f38fd5e2-8c5f-4828-99b4-73377347faad

Public Version Date

June 17, 2022

Public Version Number

3

DI Record Publish Date

April 12, 2019

Package DI Number

50885380127098

Quantity per Package

10

Contains DI Package

10885380127090

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE