Catalog Number

4992207B/A

Brand Name

Aspira®

Version/Model Number

00884450394885

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

PNG

Product Code Name

Peritoneal, drainage catheter for refractory ascites, long-term indwelling

Public Device Record Key

1fe7fc3f-6df2-4c57-8162-f7729b946286

Public Version Date

November 22, 2019

Public Version Number

1

DI Record Publish Date

November 14, 2019

Package DI Number

10884450394882

Quantity per Package

1

Contains DI Package

00884450394885

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-