Catalog Number

21214-440

Brand Name

PEDIATRIC ULTRA FLEX®ANESTHESIA BREATHING CIRCUIT

Version/Model Number

21214-440

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"

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

9ea01aa7-a03d-451a-b373-a1b1d190640b

Public Version Date

October 24, 2022

Public Version Number

5

DI Record Publish Date

September 21, 2016

Package DI Number

00612649173894

Quantity per Package

20

Contains DI Package

00612649185903

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-