GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

Address:8200 W TOWER AVE,Milwaukee,WI,53223,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Computer, diagnostic, programmable (DQK) (5) COMPUTER, DIAGNOSTIC, PROGRAMMABLE (DQK) (2) CABLE, ELECTRODE (IKD) (1) COMPUTER, BLOOD-PRESSURE (DSK) (1) Cerebral oximeter (QEM) (1) DETECTOR AND ALARM, ARRHYTHMIA (DSI) (1) Electrocardiograph (DPS) (1) MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM) (DRT) (1) MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) (MHX) (1) MONITOR, ST SEGMENT WITH ALARM (MLD) (1) Monitor, breathing frequency (BZQ) (1) Oximeter (DQA) (1) Oximeter, ear (DPZ) (1) Oximeter, tissue saturation (MUD) (1) System, measurement, blood-pressure, non-invasive (DXN) (1) System, monitoring, perinatal (HGM) (1) Thermometer, electronic, clinical (FLL) (1) ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE (CCK) (1) blood pressure cuff (DXQ) (1) Alarm, blood-pressure (DSJ) (1)

Premarket Exempt

No Yes

Clear

CLASSIC-CUF - 00195278025296 Catalog Number :

Device Description : CLASSIC-CUF ISO, ADULT, DINACLICK, 23 - 33 CM, 80369-5, SINGLE

Device Class : 2

Duns Number: 006580799

Premarket Exempt : No

Product Code : DXQ

Prescription Use : Yes

Device Count : 1

CARESCAPE ONE - 00195278288639 Catalog Number : 2087075-300

Device Description : CARESCAPE ONE MBZ323 ATO MODEL

Device Class : 2

Duns Number: 006580799

Premarket Exempt : No

Product Code : DQK, MHX, MUD, DPZ, FLL, DSK, DPS, DXN, QEM, DSJ, BZQ, CCK, DQA, DSI, DRT, MLD

Prescription Use : No

Device Count : 1

CENTRICITY PERINATAL - 00195278454386 Catalog Number :

Device Description : MD CPN 6.99 MEDICAL DEVICE

Device Class : 2

Duns Number: 006580799

Premarket Exempt : No

Product Code : HGM

Prescription Use : No

Device Count : 1

MLCL Cables - 00195278505514 Catalog Number : 2744200-001

Device Description : CLAB ECG Trunk Cable, 12-lead, AHA, 3.0 m/10 ft.

Device Class : 2

Duns Number: 006580799

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : No

Device Count : 1

CardioLab - 00195278507044 Catalog Number : 2300000-004

Device Description : Computer CardioLab Acquisition v8.0

Device Class : 2

Duns Number: 006580799

Premarket Exempt : No

Product Code : DQK

Prescription Use : No

Device Count : 1

ComboLab - 00195278507051 Catalog Number : 2300000-005

Device Description : Computer ComboLab Acquisition v8.0

Device Class : 2

Duns Number: 006580799

Premarket Exempt : No

Product Code : DQK

Prescription Use : No

Device Count : 1

MLCL Client Software - 00195278507525 Catalog Number : 5889605

Device Description : Software Medical Device GE Client Software V8.0

Device Class : 2

Duns Number: 006580799

Premarket Exempt : No

Product Code : DQK

Prescription Use : No

Device Count : 1

MLCL Upgrade - 00195278516015 Catalog Number : 5896597

Device Description : Upgrade Kit MLCL V8.0

Device Class : 2

Duns Number: 006580799

Premarket Exempt : No

Product Code : DQK

Prescription Use : No

Device Count : 1

MARS - 00840682100069 Catalog Number :

Device Class : 2

Duns Number: 784985108

Premarket Exempt : No

Product Code : DQK

Prescription Use : Yes

Device Count : 1

MUSE - 00840682100182 Catalog Number :

Device Class : 2

Duns Number: 784985108

Premarket Exempt : No

Product Code : DQK

Prescription Use : Yes

Device Count : 1

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