Hummingbird® Patient Monitor

Primary DI
10850013266019
Brand
Hummingbird® Patient Monitor
Company
IRRAS USA
Model
HICP200
Catalog number
HICP200
Device description
HICP200 Hummingbird Patient / Monitor Interconnect Cable
Published
2019-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

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
10850013266019PackageGS11In Commercial Distribution
00850013266012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085001326601910850013266019
00850013266012008500132660128500132660120850013266012

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 Temperature5 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure80 KiloPascal106 KiloPascal
Storage Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-213-4604info@irras.com

Regulatory Flags#

DUNS number
056999617
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850013266200IRRAflow Tube SetICDS 030ICDS 0302023-11-02
10850013266231HummingbirdCK 402023-10-13
10850013266248HummingbirdCK 422023-10-13
10868643000477IRRAflow® Drainage Collection SystemDCS 010DCS 0102019-09-30
10850013266187Hummingbird® Cranial Access Kit IC42-DIC42-D2020-01-29
10850013266194Hummingbird® Cranial Access KitIC42IC422020-01-29
10868643000484Hummingbird® Cranial Access KitIC40DIC40-D2019-10-10
10868643000491Hummingbird® Cranial Access KitIC40IC402019-10-10
10850013266026Hummingbird® SynergyDuoH610H6102019-10-10
10850013266033Hummingbird® Parenchymal CatheterH110H1102019-10-10
10868643000408IRRAflow®ICCU 020ICCU 0202019-01-22

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