Catalog Number

260185

Brand Name

HAMILTON-BC8010

Version/Model Number

260185

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

K152029,K163283

Product Code

BZE

Product Code Name

Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

Public Device Record Key

4cfd8067-72a4-444f-b9ce-de4620bf38e7

Public Version Date

October 24, 2022

Public Version Number

7

DI Record Publish Date

October 04, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-