Catalog Number

-

Brand Name

Triton Canister System

Version/Model Number

FG-12011

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

K142801

Product Code

PBZ

Product Code Name

Image Processing Device For Estimation Of External Blood Loss

Public Device Record Key

6a259ff3-a31f-4148-b398-6df56cfa2f59

Public Version Date

July 26, 2018

Public Version Number

1

DI Record Publish Date

June 25, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-