Catalog Number

4992507/A

Brand Name

Aspira®

Version/Model Number

00884450394915

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

DWM

Product Code Name

APPARATUS, SUCTION, PATIENT CARE

Public Device Record Key

bd72d505-4db9-4bb4-ba55-d7ce9df5eafc

Public Version Date

December 13, 2019

Public Version Number

1

DI Record Publish Date

December 05, 2019

Package DI Number

10884450394912

Quantity per Package

1

Contains DI Package

00884450394915

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-