Catalog Number

99010

Brand Name

ADULT ULTRA FLEX®

Version/Model Number

99010

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

8e2084c0-dd06-43df-a684-43903d95289b

Public Version Date

October 24, 2022

Public Version Number

2

DI Record Publish Date

June 04, 2021

Package DI Number

00612649215587

Quantity per Package

20

Contains DI Package

00612649215594

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-