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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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Welch Allyn, Inc. - 00732094325867

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; 0 hard wired patient monitoring slots and 16 telemetry channels (dual display recommended); Redundant server (RAID1+0) storage for up to 1,200 days, 110V HP LaserJet network printer; VERITAS analysis algorithm with 12-lead ECG interpretation, extended arrhythm
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094325867 ()
SCSYS-HAE-GHFCA

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094325850

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; 0 hard wired patient monitoring slots and 24 telemetry channels (dual display required); 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 monitori
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094325850 ()
SCSYS-HAE-LBFCA

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094325843

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; 0 hard wired patient monitoring slots and 24 telemetry channels (dual display required); Redundant server (RAID1+0) storage for up to 1,200 days, 110V HP LaserJet network printer; VERITAS analysis algorithm with 12-lead ECG interpretation, extended arrhythmia,
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094325843 ()
SCSYS-HAE-LHFCA

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094325669

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; 0 hard wired patient monitoring slots and 16 telemetry channels (dual display recommended); 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 monit
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094325669 ()
SCSYS-HAE-GBFCA

  • Centralized patient monitor

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. - 00732094320169

CONNEX CSAS 1.8.1 EPISODIC
WELCH ALLYN, INC.
901066
In Commercial Distribution

  • 00732094320169 ()
107980

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094320145

CONNEX CENTRAL STATION 1.8.1 - HW & SW
WELCH ALLYN, INC.
901066
Not in Commercial Distribution

  • 00732094320145 ()
107984

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094348941

FRE CTRL TELEM 110 S 16 T 8 S4 24
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094348941 ()
SCNODE-BCA-BKXEX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094348927

Surveyor Central Station with X12+ via 608 MHz frequency and multiparameter bedside monitoring capabilities; French language and CD manual; Configured CPU (custom SCNODE configuration must be determined) with 110V power and dual color LCD 24 in. monitors with high resolution; 8 hard wired patient monitoring slots and 8 telemetry channels (dual display recommended); Redundant server (RAID1+0) storage for up to 1,200 days, 110V HP LaserJet network printer; VERITAS analysis algorithm with 12-lead
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094348927 ()
SCSYS-GCE-FHFCX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094348095

TELEM 220 VAC 32S 16C S4
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094348095 ()
SCNODE-BAB-CLXFX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094348088

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 dual color LCD 24" monitors with high resolution; 16 hard wired patient monitoring slots and 16 telemetry channels (dual display required); Redundant server (RAID1+0) storage for up to 1,200 days, no network printer included; VERITAS analysis algorithm with 12- lead ECG inter
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094348088 ()
SCSYS-IAB-PDFCA

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094347197

Surveyor Central Additional Control - configured CPU English language and CD manual; 110V power; 24 monitoring slots (dual or 24" display required with additional CPU); No printer; Color LCD 24" monitor with high resolution
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094347197 ()
SCAC-AAA-DXCXX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094347180

ENG. 110V custom sl- CONTROL W DISPLAY
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094347180 ()
SCNODE-DAA-EXXEX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094345704

CSAS Episodic High Availability
WELCH ALLYN, INC.
901066
In Commercial Distribution

  • 00732094345704 ()
106900-HA

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094345568

ENG 110 VAC 32S S4 SATAS
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094345568 ()
SCNODE-CAA-CXBFX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094345551

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 110V power and dual color LCD 24" monitors with high resolution; 24 hard wired patient monitoring slots and 0 telemetry channels (dual display required); Local storage for up to 600 days, 110V HP LaserJet network printer; VERITAS analysis algorithm with 12-lead ECG interpretation, extended
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094345551 ()
SCSYS-IAE-HFFAX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094345346

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 110V power and dual color LCD 24" monitors with high resolution; 16 hard wired patient monitoring slots and 0 telemetry channels (dual display recommended); Local storage for up to 600 days, no network printer included; VERITAS analysis algorithm with 12-lead ECG interpretation, extended a
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094345346 ()
SCSYS-IAE-DBFAX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094337020

CONNEX CENTRAL STATION 1.8.3 SW ONLY
WELCH ALLYN, INC.
901066
In Commercial Distribution

  • 00732094337020 ()
108143

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094336719

Hillrom Connected Care Vitals System
WELCH ALLYN, INC.
901057
In Commercial Distribution

  • 00732094336719 ()
4400-RPMKIT

  • Multiple vital physiological parameter monitoring system, clinical

Welch Allyn, Inc. - 00732094325362

Surveyor Repeater Node with no Hardware Italian language and CD manual; 220V power; No display monitor
WELCH ALLYN, INC.
901140
Not in Commercial Distribution

  • 00732094325362 ()
SCREP-DEB-XXXXX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094325287

ITA CTRL TELEM 220 VAC 32S 24C S4
WELCH ALLYN, INC.
901140
In Commercial Distribution

  • 00732094325287 ()
SCNODE-BEB-CMXXX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094325270

ENG. 110V S4 16SL 8CH LOCAL STORAGE
WELCH ALLYN, INC.
901140
In Commercial Distribution

  • 00732094325270 ()
SCNODE-AAA-BKBEX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094325102

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 110V power and dual color LCD 24" monitors with high resolution; 0 hard wired patient monitoring slots and 4 telemetry channels (single display required); Local storage for up to 600 days, 110V HP LaserJet network printer; VERITAS analysis algorithm with 12-lead ECG interpretation, extende
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094325102 ()
SCSYS-IAE-UFFAX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094324228

ENGLISH 220V 8 SL LOCAL S4
WELCH ALLYN, INC.
901140
In Commercial Distribution

  • 00732094324228 ()
SCNODE-AAB-AJBXX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094323740

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 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 w/ 12-lead ECG interpretation
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094323740 ()
SCSYS-IAE-SHFCA

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094323290

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; Custom number of hard wired patient monitoring slots and telemetry channels; Redundant server (RAID1 +0) storage for up to 1,200 days, no network printer included; VERITAS analysis algorithm with 12-lead ECG interpretation, extended arrhythmia,
WELCH ALLYN, INC.
901137
Not in Commercial Distribution

  • 00732094323290 ()
SCSYS-IED-SDFCX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094323283

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 110V power and dual color LCD 24" monitors with high resolution; 8 hard wired patient monitoring slots and 8 telemetry channels (dual display recommended); Local storage for up to 600 days, no network printer included; VERITAS analysis algorithm with 12-lead ECG interpretation
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094323283 ()
SCSYS-IAE-FBFXX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094322361

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; Custom number of hard wired patient monitoring slots and telemetry channels; Redundant server (RAID1 +0) storage for up to 1,200 days, no network printer included; VERITAS analysis algorithm with 12-lead ECG interpretation, extended arrhythmia
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094322361 ()
SCSYS-IED-SDFEX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094320824

Surveyor Central Station w/ S4 Wifi telemetry mon. capabilities; EN lang & CD manual; Config. CPU w/ 110V pwr & dual color LCD 24" mon.s w/ high res; Custom number of hard wired patient mon. slots & telemetry channels; Redundant server (RAID1+0) storage 1,200 days, 110V HP LaserJet printer; VERITAS analysis algorithm w/ 12-lead ECG interp, ext arrhythmia, 12-lead ST segment mon., & hemodynamic calc (req options w/ hard wired patient mon. slots); Full disclosure & SC Interface; Protocol manager
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094320824 ()
SCSYS-HAE-SHFCA

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094320152

CSAS 1.8.1 CONTINUOUS
WELCH ALLYN, INC.
901066
In Commercial Distribution

  • 00732094320152 ()
107981

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094320138

CONNEX CENTRAL STATION 1.8.1 SW ONLY
WELCH ALLYN, INC.
901066
In Commercial Distribution

  • 00732094320138 ()
107985

  • 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. - 00732094320008

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; 0 hard wired patient monitoring slots and 16 telemetry channels (dual display recommended); 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

  • 00732094320008 ()
SCSYS-HAE-GHFAX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094319903

SOFTWARE SURVYOR CENTRAL REPEATER DVD
WELCH ALLYN, INC.
901011
In Commercial Distribution

  • 00732094319903 ()
419832

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094319743

Surveyor Central Additional Control - configured CPU English language and CD manual; 110V power; 8 monitoring slots (single display required with additional CPU); No printer; Color LCD 24" monitor with high resolution
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094319743 ()
SCAC-AAA-BXCXX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094319408

Surveyor Central Repeater Standalone - English language and CD manual; 220V power; No display monitor
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094319408 ()
SCREP-CAB-XXXXX

  • Centralized patient monitor

PHILIPS IntelliVue MP2 Military - 00884838064904

No Description
Philips Medizin Systeme Böblingen GmbH
867059
Not in Commercial Distribution

  • 00884838064904 ()
867059

  • Multiple vital physiological parameter monitoring system, clinical

CT Trueview - 00884838064782

Software medical device, used with a Philips Interventional X-Ray System. Creates a CT based 3D model of the coronary vessel tree. Provides a composite image of 2D X-ray exposure image and 3D model.
Philips Medical Systems Nederland B.V.
CT Trueview - 2
In Commercial Distribution

  • 00884838064782 ()
001010

  • Angiographic x-ray system application software

VesselNavigator - 00884838064775

Software medical device, used with a Philips Interventional X-Ray System. Intended to assist in the treatment of endovascular diseases during an endovascular intervention procedure.
Philips Medical Systems Nederland B.V.
VesselNavigator - 1
In Commercial Distribution

  • 00884838064775 ()
001013

  • Angiographic x-ray system application software

AneurysmFlow - 00884838064768

Software medical device, used with a Philips Interventional X-Ray System. Intended to assist with saccular cerebral aneurysm embolization, by visualizing and quantifying blood flow changes.
Philips Medical Systems Nederland B.V.
AneurysmFlow - 1
In Commercial Distribution

  • 00884838064768 ()
001015

  • Angiographic x-ray system application software
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