Catalog Number

-

Brand Name

AQUILAVIE

Version/Model Number

J10003

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)

Yes

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

K083686,K083686,K083686

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

a988c8f0-c3ae-4c7e-9b93-11567bddae34

Public Version Date

October 19, 2022

Public Version Number

1

DI Record Publish Date

October 11, 2022

Package DI Number

06936018500888

Quantity per Package

800

Contains DI Package

06936018500895

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-