Hummingbird®

Primary DI
00851680007175
Brand
Hummingbird®
Company
INNERSPACE NEURO SOLUTIONS, INC.
Model
H110MR
Catalog number
H110MR
Device description
H110MR Hummingbird Parenchymal Catheter Kit
Published
2016-11-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
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
K083378000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083378000SYNERGYInnerspace, Inc.2009-09-29GWM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851680007175PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851680007175008516800071758516800071750851680007175

GMDN Terms#

Term, Definition table
TermDefinition
Intracerebral sensor catheterA sterile flexible tube with a sensor at the distal end intended to be surgically inserted through the skull for short-term (= 30 days) access to the ventricular and/or parenchymal areas of the brain to drain cerebrospinal fluid (CSF) and to measure intracranial parameters [e.g., intracranial pressure (ICP), temperature, partial pressure of oxygen (pO2)]; it may also be intended for infusion of materials (e.g., chemotherapeutic agents, radioisotopes). It may include accessory devices intended to facilitate catheter introduction, stabilization, and/or fluid collection/infusion (e.g., stylet, bolts, drills, drainage/infusion port/reservoir). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge6French

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877.486.2473orders@hummingbirdneuromonitoring.com

Regulatory Flags#

DUNS number
080333634
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851680007151Hummingbird®HICP200HICP2002016-11-28
00851680007168Hummingbird®H310H3102016-11-28
00851680007182Hummingbird®H610MRH610MR2016-11-28
00851680007205Hummingbird®H610H6102017-07-17
00851680007199Hummingbird®STCSTC2017-07-17

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