Catalog Number

8614F-19121Z

Brand Name

ADULT ULTRA FLEX®

Version/Model Number

8614F-19121Z

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

CAI

Product Code Name

Circuit, breathing (w connector, adaptor, y piece)

Public Device Record Key

d54dca6b-1e93-4c72-9261-47fb1a9d1ce8

Public Version Date

October 24, 2022

Public Version Number

2

DI Record Publish Date

September 06, 2022

Package DI Number

00612649215976

Quantity per Package

40

Contains DI Package

00612649215983

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-