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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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PowerCHO-2 CD, w/o L-Gln w/o PR or HT,1L - 05407010120493

No Description
Lonza Verviers
BEBP12-771Q
In Commercial Distribution

  • 05407010120493 ()


  • Cell culture medium IVD

PowerCHO-2 CD, w/o L-Gln w/o PR or HT,1L - 05407010122701

No Description
Lonza Verviers
BELN12-771Q
In Commercial Distribution

  • 05407010122701 ()


  • Cell culture medium IVD

F-Socket Versatek - B970SV10

Includes 1 VersaTek Cuff, 1 VersaTek 2-Port Hub, Power Supply and AC Cord, Clinical Foot Software CD with Sensor Map, Help File and PDF of System Manual, 10 ft. USB Cable, 25 ft. Cuff Cable, Velcro Wrist/Ankle Band, Waist Belt, Sensor Carrying Case, System Carrying Case, and 1 Web-Based Training Session. System includes one of the following Sensor selections: (4) 9811E Sensors -or- (2) 9833E sensors.
Tekscan, Inc.
F-Socket VersaTek (1 Cuff) System
In Commercial Distribution

  • B970SV10 ()
SV1

  • Body-surface pressure mapping system

HR Walkway VersaTek - B970HRV40

Includes 8 VersaTek Cuffs, 4 VersaTek 2-Port Hubs, 4 Power Supplies, (1) 4-Port Powered USB Hub, Walkway Software CD with 7101QL Map and 3 Equilibration Files, Help File and PDF of System Manual, 4 HR Mat 7101E Sensors (pre-assembled into a single floor display), Hub Enclosure, 4 AC Power Cords, 4 linking and 4 - 1 in. USB cables, Wooden Shipping Crate, and 1 Training Session (USA Only)
Tekscan, Inc.
HR Walkway 4 VersaTek System
In Commercial Distribution

  • B970HRV40 ()
HRV4

  • Body-surface pressure mapping system

Welch Allyn, Inc. - 00732094320237

Surveyor Central Station with S4 Wifi telemetry and S12/S19 multiparameter bedside monitoring capabilities; Italian language and CD manual; Configured CPU (custom SCNODE configuration must be determined) with 220V power and no display monitors; 8 hard wired patient monitoring slots and 0 telemetry channels (single display required); Local storage for up to 600 days, no network printer included; VERITAS analysis algorithm with 12-lead ECG interpretation, extended arrhythmia
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094320237 ()
SCSYS-IED-ABFCX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094320084

Surveyor Central Station with S4 Wifi telemetry monitoring capabilities; English language and CD manual; Configured CPU (custom SCNODE configuration must be determined) with 110V power and dual color LCD 24" monitors with high resolution; Custom number of hard wired patient monitoring slots and telemetry channels; Redundant server (RAID1+0) storage for up to 1,200 days, 110V HP LaserJet network printer; VERITAS analysis algorithm with 12-lead ECG interpretation
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094320084 ()
SCSYS-HAE-SHFAA

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094301137

Surveyor Central Station with S4 Wifi telemetry and S12/S19 multiparameter bedside monitoring capabilities; Polish language and CD manual; Configured CPU (custom SCNODE configuration must be determined) with 220V power and no display monitors; 0 hard wired patient monitoring slots and 4 telemetry channels (single display required); Local storage for up to 600 days, no network printer included; VERITAS analysis algorithm with 12-lead ECG interpretation, extended arrhythmia
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094301137 ()
SCSYS-IGD-UBFXX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094284744

Surveyor Central Station with S4 Wifi telemetry and S12/S19 multiparameter bedside monitoring capabilities; English language and CD manual; Configured CPU (custom SCNODE configuration must be determined) with 220V power and no display monitors; 4 hard wired patient monitoring slots and 4 telemetry channels (single display required); Local storage for up to 600 days, no network printer included; VERITAS analysis algorithm with 12-lead ECG interpretation, extended arrhythmia;
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094284744 ()
SCSYS-IAD-BBFAX

  • Centralized patient monitor

F-Socket Versatek - B970SV20

Includes 2 VersaTek Cuffs, 1 VersaTek 2-Port Hub, Power Supply and AC Cord, Clinical Foot Software CD with Sensor Map, Help File and PDF of System Manual, 10 ft. USB Cable, (2) 25 ft. Cuff Cables, 2 Velcro Wrist/Ankle Bands, Waist Belt, Sensor Carrying Case, System Carrying Case, and 1 Training Session (USA Only). System includes one of the following Sensor selections: (4) 9811E Sensors -or- (2) 9833E sensors.
Tekscan, Inc.
F-Socket VersaTek (2 Cuff) System
In Commercial Distribution

  • B970SV20 ()
SV2

  • Body-surface pressure mapping system

Welch Allyn, Inc. - 00817655023274

Surveyor Central Station with S4 Wifi telemetry and S12/S19 multiparameter bedside monitoring capabilities; Polish language and CD m anual; Configured CPU (custom SCNODE configuration must be determined) with 220V power and no display monitors; 0; Local storage for up to 600 days, no network printer included; VERITAS analysis algorithm with 12-lead ECG interpretation, extended arrhythmia, 12-lead ST segment monitoring, and hemodynamic calculations (required for options with hard wired patient mo
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00817655023274 ()
SCSYS-IGD-ABFXX

  • Centralized patient monitor
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