Catalog Number

H610MR

Brand Name

Hummingbird®

Version/Model Number

H610MR

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 30, 2018

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

c79fc1d8-ff46-40c3-9a9f-c67998c17f2d

Public Version Date

June 10, 2022

Public Version Number

6

DI Record Publish Date

November 28, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-