Catalog Number

HICP200

Brand Name

Hummingbird® Patient Monitor

Version/Model Number

HICP200

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K161010,K161010

Product Code

GWM

Product Code Name

Device, Monitoring, Intracranial Pressure

Public Device Record Key

abd1e7ec-0355-4e0e-8b5d-92d339fba6cf

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

October 14, 2019

Package DI Number

10850013266019

Quantity per Package

1

Contains DI Package

00850013266012

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box