Home GUDID 10850013266026 Hummingbird® SynergyDuo
Primary DI 10850013266026
Brand Hummingbird® SynergyDuo
Company IRRAS USA
Model H610
Catalog number H610
Device description H610 Hummingbird SynergyDuo Ventricular Catheter Tray
Published 2019-10-10
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Conditional
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name GWM Device, Monitoring, Intracranial Pressure
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GWM Device, Monitoring, Intracranial Pressure Neurology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10850013266026 Package GS1 1 In Commercial Distribution 00850013266029 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10850013266026 10850013266026 00850013266029 00850013266029 850013266029 0850013266029
GMDN Terms# Term, Definition table Term Definition Intracerebral sensor catheter A 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 Type Value Unit Catheter Gauge 8.5 French
Sterilization Methods# Method table Method Ethylene Oxide
Regulatory Flags# DUNS number 056999617 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit true Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 03760409447055 SOPHYSA SOPHYSA GWM 2026-06-08 03760409447093 SOPHYSA SOPHYSA GWM 2026-06-08 07908398200008 Braincare BRAINCARE DESENVOLVIMENTO E INOVACAO TECNOLOGICA SA GWM 2026-05-08 00850013266272 IRRAflow Cranial Access Bolt Clearpoint Neuro, Inc. GWM 2025-07-24 00763000281243 Exacta Pole Clamp with laser level MEDTRONIC PS MEDICAL, INC. GWM 2025-02-17 00763000281229 Exacta Pole Clamp with laser level MEDTRONIC PS MEDICAL, INC. GWM 2025-02-16 00763000467401 NA MEDTRONIC PS MEDICAL, INC. GWM 2024-06-01 00763000406073 Becker MEDTRONIC PS MEDICAL, INC. GWM 2024-03-31 20763000467344 NA MEDTRONIC PS MEDICAL, INC. GWM 2024-03-01 20763000467351 NA MEDTRONIC PS MEDICAL, INC. GWM 2024-02-26 20763000467382 NA MEDTRONIC PS MEDICAL, INC. GWM 2024-02-26 20763000467399 NA MEDTRONIC PS MEDICAL, INC. GWM 2024-02-26 00763000406080 NA MEDTRONIC PS MEDICAL, INC. GWM 2024-02-26 00763000431259 Becker MEDTRONIC PS MEDICAL, INC. GWM 2024-02-26 00763000529307 Becker MEDTRONIC PS MEDICAL, INC. GWM 2024-02-26 00763000529369 Becker MEDTRONIC PS MEDICAL, INC. GWM 2024-02-26 00763000572877 Becker MEDTRONIC PS MEDICAL, INC. GWM 2024-02-25 00850013266203 IRRAflow Tube Set Clearpoint Neuro, Inc. GWM 2023-11-02 00763000624774 Duet® MEDTRONIC PS MEDICAL, INC. GWM 2022-03-10 00763000624781 Duet® MEDTRONIC PS MEDICAL, INC. GWM 2022-03-10 00763000624798 Duet® MEDTRONIC PS MEDICAL, INC. GWM 2022-03-10 00763000428723 Duet® MEDTRONIC PS MEDICAL, INC. GWM 2021-03-07 00763000428747 Duet® MEDTRONIC PS MEDICAL, INC. GWM 2021-03-07 00763000428754 Duet® MEDTRONIC PS MEDICAL, INC. GWM 2021-03-07 00763000428761 Duet® MEDTRONIC PS MEDICAL, INC. GWM 2021-03-07 00763000428778 Duet® MEDTRONIC PS MEDICAL, INC. GWM 2021-03-07 00763000431273 Duet® MEDTRONIC PS MEDICAL, INC. GWM 2021-02-13 20763000431307 N/A MEDTRONIC PS MEDICAL, INC. GWM 2021-02-07 00763000395971 Duet® MEDTRONIC PS MEDICAL, INC. GWM 2021-02-07 00763000395988 N/A MEDTRONIC PS MEDICAL, INC. GWM 2021-02-07
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