FDA.reportPublic FDA data

ICUpilot Software eng

Primary DI
07332699000751
Brand
ICUpilot Software eng
Company
M DIALYSIS INC.
Model
English
Catalog number
8001027
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
OUGMedical Device Data System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OUGMedical Device Data SystemGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07332699000751PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07332699000751073326990007517332699000751

GMDN Terms#

Term, Definition table
TermDefinition
Bedside information systemA dedicated assembly of devices designed to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the provision and utilization of administrative and clinical information at the patient's bedside. The system will typically provide healthcare staff with the ability to access and submit electronic patient data. It consists of dedicated combined hardware (e.g., computers, terminals, network components) and software (typically embedded).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00RT

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
824632087
Device count
1
DM exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07332699000607ISCUSflexClinical80032952016-09-24
0733269900091170 Brain Microdialysis Catheter 60/10, 4/pkg60/10P0000492016-09-24
0733269900092870 Brain Microdialysis Catheter 100/10, 4/pkg100/10P0000502016-09-24
0733269900097370 Microdialysis Bolt Catheter 130/10, 4/pkg130/10P0001312016-09-24
07332699000300Reagent KitReagentP0000112016-09-24
07332699000331Reagent Set AReagent80021632016-09-24
07332699000348Reagent Set BReagent80021642016-09-24
07332699000355Reagent Set CReagent80021652016-09-24
07332699000461Calibrator ACalibratorP0000572016-09-24
07332699000744ISCUSflexClinical80032952016-09-24
07332699000621L-P-G Reagent kitReagent80103612016-09-24
0733269900054670 Brain Microdialysis Catheter 60/10, 4/pkg60/10P0000492016-09-24
0733269900053970 Brain Microdialysis Catheter 100/10, 4/pkg100/10P0000502016-09-24
0733269900057770 Microdialysis Bolt Catheter 130/10, 4/pkg130/10P0001312016-09-24
07332699000034106 Microdialysis Pump106P0000032016-09-24
07332699000058Battery 2x3V, 106 MD Pump10680017882016-09-24
07332699000072106 Syringe10680101912016-09-24
07332699000249Microvial rack 12/pkgRackP0000282016-09-24
07332699000256Microvials 250/pkg250 x MicrovialP0000012016-09-24
07332699000263Perfusion fluid CNSCNSP0001512016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150006038N/AMEDTRONIC, INC.OUG2026-05-23
04931921049464NANIHON KOHDEN CORPORATIONOUG2026-05-20
04931921111697NANIHON KOHDEN CORPORATIONOUG2026-05-20
00199150021277NAMEDTRONIC, INC.OUG2026-05-02
00199150042784NAMEDTRONIC, INC.OUG2026-04-30
00199874112060CliniSphereMonitored Therapeutics, Inc.OUG2026-04-28
00850022853036ProSomnus RPMO2 OSA DevicePROSOMNUS SLEEP TECHNOLOGIESOUG2026-04-24
00884838129238Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-04-17
00884838129245Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-04-17
00199150002191N/AMEDTRONIC, INC.OUG2026-04-02
05404028001158Mimics FlowMaterialise NVOUG2026-03-23
05404028001172SurgiCase OnlineMaterialise NVOUG2026-03-23
05404028001189ProPlan CMF Materialise NVOUG2026-03-23
00763000994914NAMEDTRONIC, INC.OUG2026-03-22
00382904450106BD Veritor™ InfoWiFi ModuleBECTON, DICKINSON AND COMPANYOUG2026-03-13
00884838129214Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-03-09
00884838129221Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-03-09
04035479189211PatientApp 2.9BIOTRONIK SE & Co. KGOUG2026-03-04
07350149360033PD Care SystemPainDrainer ABOUG2026-03-04
00860015454706RocotoRocoto Inc.OUG2026-02-26
00860015454713RocotoRocoto Inc.OUG2026-02-26
00860015454720RocotoRocoto Inc.OUG2026-02-26
00860015454737RocotoRocoto Inc.OUG2026-02-26
00860015454768RocotoRocoto Inc.OUG2026-02-26
00860015454775RocotoRocoto Inc.OUG2026-02-26
00840241600412Kestra Provided Device Patient ApplicationKestra Medical Technologies, Inc.OUG2026-02-04
00199150002184NAMEDTRONIC, INC.OUG2026-02-01
03770034761006LIMSTARHOPI MEDICALOUG2026-01-28
03770034761013MINILIMHOPI MEDICALOUG2026-01-28
03770034761020FMCHOPI MEDICALOUG2026-01-28