Catalog Number

2616P-136

Brand Name

PEDIATRIC ULTRA FLEX®

Version/Model Number

2616P-136

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

55ba7467-dc14-4fae-9ba5-f7a9dae4babc

Public Version Date

October 24, 2022

Public Version Number

2

DI Record Publish Date

June 04, 2021

Package DI Number

00612649215549

Quantity per Package

30

Contains DI Package

00612649215556

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-