Catalog Number

00-820

Brand Name

AincA®

Version/Model Number

00-820

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

MR Safe

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

-

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

BZA

Product Code Name

CONNECTOR, AIRWAY (EXTENSION)

Public Device Record Key

33975325-4882-4453-b5cf-07aeba74ced0

Public Version Date

August 10, 2022

Public Version Number

1

DI Record Publish Date

August 02, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-