Catalog Number

-

Brand Name

Triton Sponge System- Calibration Placard

Version/Model Number

FG 12008

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

-

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

K163507

Product Code

PBZ

Product Code Name

Image Processing Device For Estimation Of External Blood Loss

Public Device Record Key

36d8167e-2b95-4a9e-a28e-be5c9f6cd967

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 09, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-