Catalog Number

1076045

Brand Name

Circuits

Version/Model Number

Disposable Pediatric Heated Passive Circuit, NO

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

BZE

Product Code Name

HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER

Public Device Record Key

cdd0df69-d887-477e-b369-a1c37a64440a

Public Version Date

October 24, 2022

Public Version Number

5

DI Record Publish Date

October 23, 2015

Package DI Number

30606959026101

Quantity per Package

10

Contains DI Package

00606959026100

Package Discontinue Date

December 31, 1999

Package Status

Not in Commercial Distribution

Package Type

PACK_OR_INNER_PACK