Catalog Number

H610

Brand Name

Hummingbird®

Version/Model Number

H610

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 19, 2019

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

Product Code

GWM

Product Code Name

Device, Monitoring, Intracranial Pressure

Public Device Record Key

ad883dfa-6fe2-4a10-9d8a-96e3e5a3eca0

Public Version Date

June 10, 2022

Public Version Number

6

DI Record Publish Date

July 17, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-