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) (5) MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) (MHX) (3) RECORDER, PAPER CHART (DSF) (1) SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE (DXN) (1)

Premarket Exempt

No Yes

Clear

Welch Allyn, Inc. - 00817655023090 Catalog Number : 30012-019-76

Device Description : Connex Cardio WAM ECG acquisition module v2, without lead wires, for use with Co Connex Cardio WAM ECG acquisition module v2, without lead wires, for use with Connex Cardio

Device Class : 2

Duns Number: 198227881

Premarket Exempt : No

Product Code : DPS

Prescription Use : Yes

Device Count : 1

Welch Allyn, Inc. - 00817655023106 Catalog Number : 419734

Device Description : QTEL v5.0.1 eSIGNATURE SOFTWARE CD

Device Class : 2

Duns Number: 198227881

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

Welch Allyn, Inc. - 00817655023151 Catalog Number : 34000-025-1004

Device Description : Z200+ Thermal printer in cool gray with 8.5 in. x 11 in. paper and accessories.

Device Class : 2

Duns Number: 198227881

Premarket Exempt : No

Product Code : DPS

Prescription Use : Yes

Device Count : 1

Welch Allyn, Inc. - 00817655023250 Catalog Number : 107422

Device Description : Software Eli Edit Pro

Device Class : 2

Duns Number: 198227881

Premarket Exempt : No

Product Code : DPS

Prescription Use : Yes

Device Count : 1

Welch Allyn, Inc. - 00817655023267 Catalog Number : 107420

Device Description : Software Eli Edit Standard

Device Class : 2

Duns Number: 198227881

Premarket Exempt : No

Product Code : DPS

Prescription Use : Yes

Device Count : 1

Welch Allyn, Inc. - 00817655023298 Catalog Number : SUR19-ZDF-CAXAX

Device Description : Surveyor S19 GEN2 Patient Monitoring System - Nellcor Sp02, ECG, Dual Temp, NIBP Surveyor S19 GEN2 Patient Monitoring System - Nellcor Sp02, ECG, Dual Temp, NIBP, IBP 1/2/3/4, CO2, starter kit, Cardiac Output, resistive color touchscreen 18.5 in. display with 1366 x 768 resolution, AC or lithium ion rechargeable battery operation; International power cord; AM12 Wired Acquisition Module with AHA 12-lead lead set with snap ends and 1 IEC 3 wire ECG patient cable with clip ends; Becton-Dickson invasive blood pressure cable (qty 2) and Y cable; Cardiac output cable and in-line t

Device Class : 2

Duns Number: 198227881

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

Welch Allyn, Inc. - 00817655023304 Catalog Number : SUR19-SDF-CXXAX

Device Description : Surveyor S19 GEN2 Patient Monitoring System - Nellcor Sp02, ECG, Dual Temp, NIBP Surveyor S19 GEN2 Patient Monitoring System - Nellcor Sp02, ECG, Dual Temp, NIBP, IBP 1/2, CO2, starter kit, resistive color touchscreen 18.5 in. display with 1366 x 768 resolution, AC or lithium ion rechargeable battery operation; International power cord; AM12 Wired Acquisition Module with AHA 12-lead lead set with snap ends and 1 IEC 3 wire ECG patient cable with clip ends; Becton-Dickson invasive blood pressure cable (qty 2) and Y cable; No cardiac output cable; No printer; LAN; No mounting

Device Class : 2

Duns Number: 198227881

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

Welch Allyn, Inc. - 00817655023311 Catalog Number : RSCRIBE-6AC-XXCAA

Device Description : RScribe 12-Lead Multi-Channel Electrocardiograph - version 6, current software C RScribe 12-Lead Multi-Channel Electrocardiograph - version 6, current software CD; WAM Wireless Acquisition Module; Adult and pediatric interpretation; Software kit; No power cord; No printer; Suction electrodes (6) and clamps (4); AHA 10 wire, 12-lead lead set with banana plugs; Standard connectivity-includes XML order and XML/PDF output (required for HL7 interfacing)

Device Class : 2

Duns Number: 198227881

Premarket Exempt : No

Product Code : DPS

Prescription Use : Yes

Device Count : 1

Welch Allyn, Inc. - 06932825396010 Catalog Number : RPM-BP100

Device Description : Welch Allyn Home Blood Pressure Monitor (1500 Series) with D-Ring Standard Wide Welch Allyn Home Blood Pressure Monitor (1500 Series) with D-Ring Standard Wide Cuff (22-42cm), 4 Alkaline AA batteries. Home Blood Pressure Monitor may be used standalone, or in conjunction with the Welch Allyn Home Hypertension Program Clinical Portal and Patient Application. May also be integrated into third party Remote Patient Monitoring (RPM) solutions.

Device Class : 2

Duns Number: 198227881

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Welch Allyn, Inc. - 10817655021130 Catalog Number : 716-0237-002

Device Description : Assurance Paper, Z-fold pad, red grid, perforated with blank header, 8.5 in. x 1 Assurance Paper, Z-fold pad, red grid, perforated with blank header, 8.5 in. x 11 in. (216mm x 279mm).For use with 8300/8500, Atria, Eclipse Plus/ Premier, and Quest. 200 sheets/pad, Price per pad.

Device Class : 1

Duns Number: 198227881

Premarket Exempt : Yes

Product Code : DSF

Prescription Use : No

Device Count : 1

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