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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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BPMS Evolution - B970BCE533010

Includes 1 Evolution Handle, BPMS Clinical Software CD with Sensor Map corresponding to Sensor 5330, Help File and PDF of System Manual, (1) 5330 Sensor, System Carrying Case, Sensor Carrying Case, and 1 Web-Based Training Session (USA Only)
Tekscan, Inc.
BPMS 1 System (5330 Sensors)
In Commercial Distribution

  • B970BCE533010 ()
BCE5330-1

  • Body-surface pressure mapping system

BPMS Evolution - B970BCE531510

Includes 1 Evolution Handle, BPMS Clinical Software CD with Sensor Map corresponding to Sensor 5315, Help File and PDF of System Manual, System Carrying Case, Sensor Carrying Case, (2) 5315 Sensors with Sensor Cover, and 1 Web-Based Training Session (USA Only)
Tekscan, Inc.
BPMS 1 System (5315 Sensors)
In Commercial Distribution

  • B970BCE531510 ()
BCE5315-1

  • Body-surface pressure mapping system

Welch Allyn, Inc. - 00732094294101

RScribe 12-Lead Multi-Channel Electrocardiograph - version 7, current software CD; No Acquisition Module; Adult and pediatric interpretation; Software kit; No power cord; No printer; No accessories; No patient cable; Standard connectivity-includes XML order and XML/PDF output (required for HL7 interfacing)
WELCH ALLYN, INC.
901127
Not in Commercial Distribution

  • 00732094294101 ()
RSCRIBE-7EC-XXDXA

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094263015

RScribe 12-Lead Multi-Channel Electrocardiograph - version 6, current software CD; No Acquisition Module; Adult and pediatric interpretation; Software kit; No power cord; No printer; No accessories; No patient cable; Standard connectivity-includes XML order and XML/PDF output (required for HL7 interfacing)
WELCH ALLYN, INC.
901127
In Commercial Distribution

  • 00732094263015 ()
RSCRIBE-6EC-XXDXA

  • Electrocardiograph, professional, multichannel

Walkway Evolution - B970VH40

Includes 4 Evolution Handles, (1) 4-Port Powered USB Hub, Walkway Software CD with 5101QL Map and 3 Factory Equilibration Files, Help File and PDF of System Manual, (4) 5101 Sensors (pre-assembled into a single floor display), and 1 Training Session (USA Only)
Tekscan, Inc.
Very HR Walkway 4 System
In Commercial Distribution

  • B970VH40 ()
VH4

  • Body-surface pressure mapping system

Walkway Evolution - B970VH30

Includes 3 Evolution Handles, (1) 4-Port Powered USB Hub, Walkway Software CD with 5101TL Map and 3 Factory Equilibration Files, Help File and PDF of System Manual, (3) 5101 Sensors (pre-assembled into a single floor display), and 1 Training Session (USA Only)
Tekscan, Inc.
Very HR Walkway 3 System
In Commercial Distribution

  • B970VH30 ()
VH3

  • Body-surface pressure mapping system

BPMS Evolution - B970BCE80

Includes 8 Evolution Handles, (2) 4-Port Powered USB Hubs, BPMS Clinical Software CD with 5315O Map, Help File and PDF of System Manual, System Carrying Case, Sensor Carrying Case, (8) 5315 Sensors with 1 Eight-Pocket Sensor Cover, and 1 Training Session (USA Only)
Tekscan, Inc.
BCE8
In Commercial Distribution

  • B970BCE80 ()
BCE8

  • Body-surface pressure mapping system

BPMS Evolution - B970BCE40

Includes 4 Evolution Handles, (1) 4-Port Powered USB Hub, BPMS Clinical Software CD with 5315QL Map, Help File and PDF of System Manual, System Carrying Case, Sensor Carrying Case, (4) 5315 Sensors with 1 Four-Pocket Sensor Cover, and 1 Training Session (USA Only)
Tekscan, Inc.
BCE4
In Commercial Distribution

  • B970BCE40 ()
BCE4

  • Body-surface pressure mapping system

Prosthetic Evolution - B970PE10

Includes 1 Evolution Handle, Clinical Foot Software CD with Sensor Map, Help File and PDF of System Manual, Sensor Carrying Case, System Carrying Case, and 1 Web-Based Training Session. System includes one of the following Sensor selections: (4) 9801 Sensors -or- (2) 9830 sensors.
Tekscan, Inc.
Prosthetic 1 (1 Handle) System
In Commercial Distribution

  • B970PE10 ()
PE1

  • Body-surface pressure mapping system

MatScan VersaTek - B970MV1SPORTS0

Includes MatScan 3150E Sensor installed in floor display with 1 VersaTek Cuff, 1 VersaTek 2-Port Hub, Power Supply and AC Cord, SportsAT Software CD with MatScan 3150 Sensor Map, Help File and PDF of System Manual, 10 ft. USB Cable, 10 ft. Cuff Cable
Tekscan, Inc.
MatScan VersaTek Platform with SportsAT Software
In Commercial Distribution

  • B970MV1SPORTS0 ()
MV1-SPORTS

  • Body-surface pressure mapping system

BPMS Evolution - B970BCE531520

Includes 2 Evolution Handles, BPMS Clinical Software CD with (2) 5315 Sensor Map(s), Help File and PDF of System Manual, System Carrying Case, Sensor Carrying Case, (4) 5315 Sensors with 2 Sensor Covers or 1 Two-Pocket Sensor Cover, and 1 Training Session (USA Only)
Tekscan, Inc.
BPMS 2 System (5315 Sensors)
In Commercial Distribution

  • B970BCE531520 ()
BCE5315-2

  • Body-surface pressure mapping system

CONFORMat Evolution - B970CCE20

Includes 2 Evolution Handles, (1) 4-Port Powered USB Hub, CONFORMat Clinical Software CD with CONFORMat and CONFORMat Dual Maps, Help File and PDF of System Manual, (2) 5330 Sensors, System Carrying Case, Sensor Carrying Tube, Quick Start Guide, and 1 Training Session (USA Only)
Tekscan, Inc.
CONFORMat 2 System
In Commercial Distribution

  • B970CCE20 ()
CCE2

  • Body-surface pressure mapping system

BPMS Evolution - B970BCE540020

Includes 2 Evolution Handles, BPMS Clinical Software CD with (2) 5400N Sensor Map(s), Help File and PDF of System Manual, System Carrying Case, Sensor Carrying Case, (2) 5400N Sensors with 2 Sensor Covers or 1 Two-Pocket Sensor Cover, and 1 Training Session (USA Only)
Tekscan, Inc.
BCE5400-2
In Commercial Distribution

  • B970BCE540020 ()
BCE5400-2

  • Body-surface pressure mapping system

BPMS Evolution - B970BCE535020

Includes 2 Evolution Handles, BPMS Clinical Software CD with (2) 5350 Sensor Map(s), Help File and PDF of System Manual, System Carrying Case, Sensor Carrying Case, (4) 5350 Sensors with 2 Sensor Covers or 1 Two-Pocket Sensor Cover and 1 Training Session (USA Only)
Tekscan, Inc.
BPMS 2 System (5350 Sensors)
In Commercial Distribution

  • B970BCE535020 ()
BCE5350-2

  • Body-surface pressure mapping system

Welch Allyn, Inc. - 00732094319026

RScribe 12-Lead Multi-Channel Electrocardiograph - version 6, current software CD; WAM Wireless Acquisition Module; Non-interpretive; Software kit; No power cord; No printer; No accessories; AHA 10 wire, 12-lead lead set with banana plugs; Standard connectivity-includes XML order and XML/PDF output (required for HL7 interfacing)
WELCH ALLYN, INC.
901127
In Commercial Distribution

  • 00732094319026 ()
RSCRIBE-6BC-XXDAA

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094285574

RScribe 12-Lead Multi-Channel Electrocardiograph - version 6, current software CD; AM12 Wired Acquisition Module, Non-interpretive; Software kit; International power cord; No printer; No accessories; IEC 10 wire, 12-lead lead set with banana plugs; Standard connectivity-includes XML order and XML/PDF output (required for HL7 interfacing)
WELCH ALLYN, INC.
901127
In Commercial Distribution

  • 00732094285574 ()
RSCRIBE-6DC-DXDBA

  • Electrocardiograph, professional, multichannel

Huge-Mat Evolution - B970MXLE20

Includes 2 Evolution Handles, 1 Four-Port USB Hub, Research Walkway Software CD with 5400ND Map, Help File and PDF of System Manual, 2 HugeMat 5400N Sensors pre-assembled into a single floor display, Neoprene Cover (12'x3'), Hub Enclosure, Wooden Shipping Crate, and 1 Training Session (USA only)
Tekscan, Inc.
HugeMat Walkway 2 Evolution System
In Commercial Distribution

  • B970MXLE20 ()
MXLE2

  • Body-surface pressure mapping system

Welch Allyn, Inc. - 00732094309201

RScribe 12-Lead Multi-Channel Electrocardiograph - version 6, current software CD; WAM Wireless Acquisition Module; Adult and pediatric interpretation; Software kit; International power cord; No printer; No accessories; IEC 10 wire, 12-lead lead set with banana plugs; Standard connectivity-includes XML order and XML/PDF output (required for HL7 interfacing)
WELCH ALLYN, INC.
901127
In Commercial Distribution

  • 00732094309201 ()
RSCRIBE-6GC-XXCBX

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094263145

RScribe 12-Lead Multi-Channel Electrocardiograph - version 6, current software CD; WAM Wireless Acquisition Module; Adult and pediatric interpretation; Software kit; International power cord; No printer; No accessories; IEC 10 wire, 12-lead lead set with banana plugs; Standard connectivity-includes XML order and XML/PDF output (required for HL7 interfacing)
WELCH ALLYN, INC.
901127
In Commercial Distribution

  • 00732094263145 ()
RSCRIBE-6AC-DXDBA

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094263060

RScribe 12-Lead Multi-Channel Electrocardiograph - version 6, current software CD; AM12 Wired Acquisition Module; Adult and pediatric interpretation; Software kit; No power cord; No printer; No accessories; IEC 10 wire, 12-lead lead set with banana plugs; Standard connectivity-includes XML order and XML/PDF output (required for HL7 interfacing)
WELCH ALLYN, INC.
901127
In Commercial Distribution

  • 00732094263060 ()
RSCRIBE-6CC-XXDBA

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094263053

RScribe 12-Lead Multi-Channel Electrocardiograph - version 6, current software CD; No Acquisition Module; Adult and pediatric interpretation; Software kit; No power cord; No printer; No accessories; IEC 10 wire, 12-lead lead set with banana plugs; Standard connectivity-includes XML order and XML/PDF output (required for HL7 interfacing)
WELCH ALLYN, INC.
901127
In Commercial Distribution

  • 00732094263053 ()
RSCRIBE-6EC-XXDBA

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094263046

RScribe 12-Lead Multi-Channel Electrocardiograph - version 6, current software CD; No Acquisition Module; Adult and pediatric interpretation; Software kit; No power cord; No printer; No accessories; IEC 10 wire, 12-lead lead set with banana plugs; Advanced connectivity-includes DICOM order and output and XML order and XML/PDF output
WELCH ALLYN, INC.
901127
In Commercial Distribution

  • 00732094263046 ()
RSCRIBE-6EC-XXDBB

  • Electrocardiograph, professional, multichannel

BPMS Evolution - B970BCE5315535010

Includes 1 Evolution Handle, BPMS Clinical Software CD with Sensor Map corresponding to Sensor 5350, Help File and PDF of System Manual, System Carrying Case, Sensor Carrying Case, (1) 5315 Sensor with Sensor Cover and (1) 5350 Sensor with Sensor Cover, and 1 Web-Based Training Session (USA Only)
Tekscan, Inc.
BPMS 1 System (5315-5350 Sensors)
In Commercial Distribution

  • B970BCE5315535010 ()
BCE5315-5350-1

  • Body-surface pressure mapping system

Welch Allyn, Inc. - 00732094321692

RScribe 12-Lead Multi-Channel Electrocardiograph - version 6, current software CD; AM12 Wired Acquisition Module; Adult and pediatric interpretation; Software kit; No power cord; No printer; No accessories; AHA 10 wire, 12-lead lead set with banana plugs; Standard connectivity- includes XML order and XML/PDF output (required for HL7 interfacing)
WELCH ALLYN, INC.
901127
In Commercial Distribution

  • 00732094321692 ()
RSCRIBE-6CC-XXDAA

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094334944

RScribe 12-Lead Multi-Channel Electrocardiograph - version 6, current software CD; AM12 Wired Acquisition Module; Adult and pediatric interpretation; Software kit; US/Canada power cord; No printer; No accessories; IEC 10 wire, 12-lead lead set with banana plugs; Standard connectivity-includes XML order and XML/PDF output (required for HL7 interfacing)
WELCH ALLYN, INC.
901127
In Commercial Distribution

  • 00732094334944 ()
RSCRIBE-6CC-AXDBA

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094283419

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; No accessories; AHA 10 wire, 12-lead lead set with banana plugs; Standard connectivity- includes XML order and XML/PDF output (required for HL7 interfacing)
WELCH ALLYN, INC.
901127
In Commercial Distribution

  • 00732094283419 ()
RSCRIBE-6AC-XXDAA

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094263121

RScribe 12-Lead Multi-Channel Electrocardiograph - version 6, current software CD; WAM Wireless Acquisition Module; Non-interpretive; Software kit; Australia power cord; No printer; Suction electrodes (6) and clamps (4); IEC 10 wire, 12-lead lead set with banana plugs; Standard connectivity-includes XML order and XML/PDF output (required for HL7 interfacing)
WELCH ALLYN, INC.
901127
In Commercial Distribution

  • 00732094263121 ()
RSCRIBE-6BC-BXCBA

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094263107

RScribe 12-Lead Multi-Channel Electrocardiograph - version 6, current software CD; AM12 Wired Acquisition Module; Adult and pediatric interpretation; Software kit; US/Canada power cord; No printer; No accessories; IEC 10 wire, 12-lead lead set with banana plugs; Advanced connectivity-includes DICOM order and output and XML order and XML/PDF output
WELCH ALLYN, INC.
901127
In Commercial Distribution

  • 00732094263107 ()
RSCRIBE-6CC-AXDBB

  • Electrocardiograph, professional, multichannel

MatScan VersaTek - B970MV1RES0

Includes MatScan 3150E Sensor installed in floor display with 1 VersaTek Cuff, 1 VersaTek 2-Port Hub, Power Supply and AC Cord, FootMat Software for Researchers CD with MatScan 3150 Sensor Map, Help File and PDF of System Manual, 10 ft. USB Cable, 10 ft. Cuff Cable, and 1 Web-Based Training Session
Tekscan, Inc.
MatScan VersaTek Platform with FootMat Software for Researchers
In Commercial Distribution

  • B970MV1RES0 ()
MV1-RES

  • Body-surface pressure mapping system

MatScan VersaTek - B970MV10

Includes MatScan 3150E Sensor installed in floor display with 1 VersaTek Cuff, 1 VersaTek 2-Port Hub, Power Supply and AC Cord, FootMat Software for Clinicians CD with MatScan 3150 Map, Help File and PDF of System Manual, 10 ft. USB Cable, 10 ft. Cuff Cable, and 1 Web-Based Training Session
Tekscan, Inc.
MatScan VersaTek Platform with FootMat Software for Clinicians
In Commercial Distribution

  • B970MV10 ()
MV1

  • Body-surface pressure mapping system
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