Home GUDID 10850013266200 IRRAflow Tube Set
Primary DI 10850013266200
Brand IRRAflow Tube Set
Company IRRAS USA
Model ICDS 030
Catalog number ICDS 030
Published 2023-11-02
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx false
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 00850013266265 Package GS1 1 In Commercial Distribution 10850013266200 Package GS1 5 In Commercial Distribution 00850013266203 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 00850013266265 00850013266265 850013266265 0850013266265 10850013266200 10850013266200 00850013266203 00850013266203 850013266203 0850013266203
GMDN Terms# Term, Definition table Term Definition Cerebrospinal fluid pressure regulation system, gravity-flow An assembly of electronic devices designed to simultaneously monitor cerebrospinal fluid (CSF) pressure and drain CSF at a rate regulated by the desired intracranial or in-tube CSF pressure. It consists of a control unit, a user interface, and provides CSF drainage via gravity; it is connected to disposable tubing/collection bags and a dedicated CSF access device (e.g., catheter, needle) inserted into the cerebral ventricles or subarachnoid (intrathecal) space of the spinal column. It is typically used in head trauma, normal pressure hydrocephalus (NPH) diagnostics, and during major vascular surgery.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature -25 Degrees Celsius 50 Degrees Celsius
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 false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false 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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