Catalog Number

4992306

Brand Name

Aspira Valve Repair Kit

Version/Model Number

4992306

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FJS

Product Code Name

CATHETER, PERITONEAL, LONG-TERM INDWELLING

Public Device Record Key

441f7e5f-d624-49ba-b017-7fd7ea39ddc3

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 20, 2015

Package DI Number

10801741045056

Quantity per Package

5

Contains DI Package

00801741045059

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA