Catalog Number

1134437

Brand Name

Circuits

Version/Model Number

Circuit, Disposable, 15mm, Non-Heated, Passive

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

CBK

Product Code Name

Ventilator, continuous, facility use

Public Device Record Key

4545ca4d-540e-45b9-947a-b90c2cb96046

Public Version Date

October 24, 2022

Public Version Number

3

DI Record Publish Date

September 18, 2020

Package DI Number

30606959051752

Quantity per Package

10

Contains DI Package

00606959051751

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Multipack