FDA.reportPublic FDA data

Hummingbird®

Primary DI
00851680007151
Brand
Hummingbird®
Company
INNERSPACE NEURO SOLUTIONS, INC.
Model
HICP200
Catalog number
HICP200
Device description
Hummingbird ICP Control Module with Patient Cable Module
Published
2016-11-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWMDevice, Monitoring, Intracranial Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWMDevice, Monitoring, Intracranial PressureNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161010000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161010000HICP200 Patient/Monitor Interconnect CableInnerspace Neuro Solutions, Inc.2016-10-20GWM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851680007151PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851680007151008516800071518516800071510851680007151

GMDN Terms#

Term, Definition table
TermDefinition
Intracranial pressure monitorAn electrically-powered device intended for intermittent or continuous measurement and display of intracranial pressure (ICP). It is used in conjunction with an invasive intracranial device (e.g., intracerebral sensor catheter) that transmits electrical signals via connected cables or pressure signals via tubing (e.g., via the air pouch method). It may include an alarm designed to alert clinical staff to an elevated ICP and may also produce a strip-chart recording or display of the ICP waveform that enables interpretation of long-term ICP trends.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure80 KiloPascal106 KiloPascal
Handling Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature15 Degrees Celsius39 Degrees Celsius
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877.486.2473customerservice@hummingbirdneuro.com

Regulatory Flags#

DUNS number
080333634
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851680007168Hummingbird®H310H3102016-11-28
00851680007175Hummingbird®H110MRH110MR2016-11-28
00851680007182Hummingbird®H610MRH610MR2016-11-28
00851680007205Hummingbird®H610H6102017-07-17
00851680007199Hummingbird®STCSTC2017-07-17

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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20763000467399NAMEDTRONIC PS MEDICAL, INC.GWM2024-02-26
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00763000572877BeckerMEDTRONIC PS MEDICAL, INC.GWM2024-02-25
00850013266203IRRAflow Tube SetClearpoint Neuro, Inc.GWM2023-11-02
00763000624774Duet®MEDTRONIC PS MEDICAL, INC.GWM2022-03-10
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00763000428778Duet®MEDTRONIC PS MEDICAL, INC.GWM2021-03-07
00763000431273Duet®MEDTRONIC PS MEDICAL, INC.GWM2021-02-13
20763000431307N/AMEDTRONIC PS MEDICAL, INC.GWM2021-02-07
00763000395971Duet®MEDTRONIC PS MEDICAL, INC.GWM2021-02-07
00763000395988N/AMEDTRONIC PS MEDICAL, INC.GWM2021-02-07
00763000406004Duet®MEDTRONIC PS MEDICAL, INC.GWM2021-02-07
00763000406011Duet®MEDTRONIC PS MEDICAL, INC.GWM2021-02-07