Catalog Number

161001

Brand Name

HAMILTON-C1

Version/Model Number

161001

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

-

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

BZR

Product Code Name

Mixer, Breathing Gases, Anesthesia Inhalation

Public Device Record Key

43507655-76e8-4ab1-a3e4-9a41b716f5ee

Public Version Date

January 27, 2022

Public Version Number

4

DI Record Publish Date

October 21, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-