Catalog Number

2705Y-136

Brand Name

PEDIATRIC ULTRA FLEX®ANESTHESIA BREATHING CIRCUIT

Version/Model Number

2705Y-136

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 08, 2021

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"

Yes

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

5645cb9a-05fd-44a5-af3e-468708015f16

Public Version Date

October 24, 2022

Public Version Number

5

DI Record Publish Date

September 22, 2016

Package DI Number

00612649171951

Quantity per Package

30

Contains DI Package

00612649187501

Package Discontinue Date

April 08, 2021

Package Status

Not in Commercial Distribution

Package Type

-