WELCH ALLYN, INC.

Address:7865 NORTH 86TH ST.,MILWAUKEE,WI,53224,US

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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

Electrocardiograph (DPS) (6) ELECTROCARDIOGRAPH, AMBULATORY, WITH ANALYSIS ALGORITHM (MLO) (1) Electrocardiograph, ambulatory (without analysis) (MWJ) (1) MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) (MHX) (1) Oximeter (DQA) (1)

Premarket Exempt

No Yes

Clear

Welch Allyn, Inc. - 00817655020853 Catalog Number : H3PLUS-CAE-XXXXX

Device Description : H3+ 3-channel digital Holter Recorder - 7-day, includes carry case with clip, an H3+ 3-channel digital Holter Recorder - 7-day, includes carry case with clip, and hookup kit (not available for US); Multiple languages and CD manual (except Brazilian Portuguese); IEC 5 wire, 15 inch (38cm), LeadForm patient cable with snap ends

Device Class : 2

Duns Number: 198227881

Premarket Exempt : No

Product Code : MWJ

Prescription Use : Yes

Device Count : 1

Welch Allyn, Inc. - 00817655020860 Catalog Number : HSCRIBE-6AA-CXXXX

Device Description : HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia a HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Turnkey system with configured CPU and color LCD 24 in. monitor with 1920 x 1080 resolution; UK power cord; No printer; No connectivity

Device Class : 2

Duns Number: 198227881

Premarket Exempt : No

Product Code : MLO

Prescription Use : Yes

Device Count : 1

Welch Allyn, Inc. - 00817655020952 Catalog Number : 88188-001-50

Device Description : Hscribe Web Upload software kit

Device Class : 2

Duns Number: 198227881

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

Welch Allyn, Inc. - 00817655021058 Catalog Number : 11027-024-50

Device Description : Resting ECG connectivity gateway software v.5.0.0

Device Class : 2

Duns Number: 198227881

Premarket Exempt : No

Product Code : DPS

Prescription Use : No

Device Count : 1

Welch Allyn, Inc. - 00817655021294 Catalog Number : 419770

Device Description : DVD SOFTWARE XScribe CP v4.0.3

Device Class : 2

Duns Number: 198227881

Premarket Exempt : No

Product Code : DPS

Prescription Use : Yes

Device Count : 1

Welch Allyn, Inc. - 00817655022598 Catalog Number : CC-RXX-WADX

Device Description : Connex Cardio PC based 12-Lead Multi-Channel Resting ECG - software, Connex Card Connex Cardio PC based 12-Lead Multi-Channel Resting ECG - software, Connex Cardio WAM wireless acquisition module, AHA 10 wire, 12-lead lead set with banana plugs, CardioSens Ultra II resting tab electrodes (pouch of 100), Clear Choice adapter clips (set of 10), Connex Cardio UTK, DICOM

Device Class : 2

Duns Number: 198227881

Premarket Exempt : No

Product Code : DPS

Prescription Use : Yes

Device Count : 1

Welch Allyn, Inc. - 00817655022604 Catalog Number : CC-RXX-WAXX

Device Class : 2

Duns Number: 198227881

Premarket Exempt : No

Product Code : DPS

Prescription Use : Yes

Device Count : 1

Welch Allyn, Inc. - 00817655022611 Catalog Number : CC-RXX-AADX

Device Description : Connex Cardio PC based 12-Lead Multi-Channel Resting ECG - software, Connex Card Connex Cardio PC based 12-Lead Multi-Channel Resting ECG - software, Connex Cardio AM12 wired acquisition module, AHA 10 wire, 12-lead lead set with banana plugs, CardioSens Ultra II resting tab electrodes (pouch of 100), Clear Choice adapter clips (set of 10), DICOM

Device Class : 2

Duns Number: 198227881

Premarket Exempt : No

Product Code : DPS

Prescription Use : Yes

Device Count : 1

Welch Allyn, Inc. - 00817655022628 Catalog Number : CC-RXX-AAXX

Device Description : Connex Cardio PC based 12-Lead Multi-Channel Resting ECG - software, Connex Card Connex Cardio PC based 12-Lead Multi-Channel Resting ECG - software, Connex Cardio AM12 wired acquisition module, AHA 10 wire, 12-lead lead set with banana plugs, CardioSens Ultra II resting tab electrodes (pouch of 100), Clear Choice adapter clips (set of 10)

Device Class : 2

Duns Number: 198227881

Premarket Exempt : No

Product Code : DPS

Prescription Use : Yes

Device Count : 1

Welch Allyn, Inc. - 00817655022956 Catalog Number : 419593

Device Description : CONNEX CARDIO USB v1.1.1 SFW & UM

Device Class : 2

Duns Number: 198227881

Premarket Exempt : No

Product Code : DQA

Prescription Use : No

Device Count : 1

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