Catalog Number

H610

Brand Name

Hummingbird® SynergyDuo

Version/Model Number

H610

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K083378,K083378

Product Code

GWM

Product Code Name

Device, Monitoring, Intracranial Pressure

Public Device Record Key

fffef5ba-2b67-449b-b2aa-7aae3dba1be2

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

October 10, 2019

Package DI Number

10850013266026

Quantity per Package

1

Contains DI Package

00850013266029

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box