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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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Panel PC - 05065012584516

Medical computer loaded with Quadsense software.
EVENTUM ORTHOPAEDICS LTD
PC001
In Commercial Distribution

  • 05065012584516 ()


  • Arthroplasty force sensor display unit

Welch Allyn, Inc. - 00732094043488

CCW Software Viewing License (per computer)
WELCH ALLYN, INC.
901047
In Commercial Distribution

  • 00732094043488 ()
SW-CCW-LIC

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094043433

CardioPerfect Pro Telemedicine option (per computer)
WELCH ALLYN, INC.
901047
In Commercial Distribution

  • 00732094043433 ()
SW-CCW-TELEM

  • Electrocardiograph, professional, multichannel

ORTHO - 10758750011582

ORTHO VERSEIA™ Pipetter Workstation - computer
ORTHO-CLINICAL DIAGNOSTICS, INC.
6842852
In Commercial Distribution

  • 10758750011582 ()
6842852

  • Enzyme immunoassay (EIA) analyser IVD

Vita CR System - 60889971067692

NB VITA CR SOLUTION W / COMPUTER
CARESTREAM HEALTH, INC.
Vita CR System
In Commercial Distribution

  • 60889971067692 ()
1067693

  • Computed radiography digital imaging scanner

Pryor - 00761887004474

5 LEG GEAR BASE COMPUTER CART
PRYOR PRODUCTS
500C
In Commercial Distribution

  • 00761887004474 ()
500C

  • Freestanding/bed-attached intravenous pole

FUSION Compact ™ - 00763000099787

COMPUTER 9735602R FUSION COMP RFB LOADED
MEDTRONIC NAVIGATION, INC.
9735602R
In Commercial Distribution

  • 00763000099787 ()


  • Multi-purpose stereotactic surgery system

Serial Computer Interface Cable - 04260166370065

No Description
Stockert GmbH
39D-06X15
In Commercial Distribution

  • 04260166370065 ()


  • Electrical catheter connection cable, reusable

Serial Computer Interface Cable - 04260166370058

No Description
Stockert GmbH
S7013
In Commercial Distribution

  • 04260166370058 ()


  • Electrical catheter connection cable, reusable

ESH, "CE", (New Computer) - M52513410020

No Description
HELENA LABORATORIES CORPORATION
1341002
In Commercial Distribution

  • M52513410020 ()


  • Pipetting system IVD

EPOC HOST MOBILE COMPUTER - 00809708016678

No Description
Epocal Inc
HH-0003-00-00
In Commercial Distribution

  • 00809708016678 ()
HH-0003-00-00

  • Metabolic profile clinical chemistry analyser IVD

Tablet computer + Pre-installed Software - 07290113780262

No Description
AUGMEDICS LTD
ACC00001
In Commercial Distribution

  • 07290113780262 ()


  • Multi-purpose stereotactic surgery system

All-in-one computer + Pre-installed Software - 07290113780231

No Description
AUGMEDICS LTD
ACC00008
In Commercial Distribution

  • 07290113780231 ()


  • Multi-purpose stereotactic surgery system

ABPCare - 00856298006176

No Description
SCOTTCARE CORPORATION, THE
ABPCare
In Commercial Distribution

  • 00856298006176 ()
101367

  • Ambulatory services information system application software

Ultiri™ - 05415067037626

Measurement System
LIGHTLAB IMAGING, INC.
1015082
In Commercial Distribution

  • 05415067037626 ()
1015082

  • Coronary optical coherence tomography system

Vista Interface w/turbine flow sensor - 00850644007091

Vista Interface System
Vacumed
17003
In Commercial Distribution

  • 00850644007091 ()
17003

  • Cardiopulmonary stress exercise monitoring system

Vista Interface - 00850644007084

Vista Interface System
Vacumed
17001
In Commercial Distribution

  • 00850644007084 ()
17001

  • Cardiopulmonary stress exercise monitoring system

Vista Mini-CPX Silver Edition - 00850644007077

Vista Interface System
Vacumed
17670
In Commercial Distribution

  • 00850644007077 ()
17670

  • Cardiopulmonary stress exercise monitoring system

Vista MX2 (Gold Edition) - 00850644007060

Vista Interface System
Vacumed
17594G
In Commercial Distribution

  • 00850644007060 ()
17594G

  • Cardiopulmonary stress exercise monitoring system

Vista-MX2 - 00850644007053

Vista Interface System
Vacumed
17594
In Commercial Distribution

  • 00850644007053 ()
17594

  • Cardiopulmonary stress exercise monitoring system

Vista-MX (Gold Edition) - 00850644007046

Vista Interface System
Vacumed
17593
In Commercial Distribution

  • 00850644007046 ()
17593

  • Cardiopulmonary stress exercise monitoring system

Vista-MX Metabolic Measurement System - 00850644007039

Vista Interface System
Vacumed
17590
In Commercial Distribution

  • 00850644007039 ()
17590

  • Cardiopulmonary stress exercise monitoring system

Cardiopulmonary stress exercise monitoring system - 00850644007022

Vista Interface System
Vacumed
17590 REV2-YD
In Commercial Distribution

  • 00850644007022 ()
YD17590

  • Cardiopulmonary stress exercise monitoring system

M SERIES CCT - 00847946099312

Defibrillator ,MAIN,CCT,MAN-1,12 LD,SPO2,ETCO2,NIBP,IBP,TEMP,BIPHASIC,AC,AW
Zoll Medical Corporation
40021911100124300
In Commercial Distribution

  • 00847946099312 ()

  • 10.2" x 10.3" x 8.7"


  • Rechargeable professional automated external defibrillator

M SERIES CCT - 00847946007331

Defibrillator ,MAIN,CCT,MAN-1,12 LEAD,MUSE,SPO2,ETCO2,NIBP,IBP,TEMP,BIP,PACE,RCD,SMR,CDMK,AC,DMST
Zoll Medical Corporation
40022961100124010
In Commercial Distribution

  • 00847946007331 ()

  • 10.2" x 10.3" x 8.7"


  • Rechargeable professional automated external defibrillator

M SERIES CCT - 00847946007324

Defibrillator ,MAIN,CCT,MAN-1,12 LEAD,MUSE,SPO2,ETCO2,NIBP,IBP,TEMP,BIP,PACE,RCD,SMR,CDMK,AC,DMST
Zoll Medical Corporation
40022911100124010
In Commercial Distribution

  • 00847946007324 ()

  • 10.2" x 10.3" x 8.7"


  • Rechargeable professional automated external defibrillator

M SERIES CCT - 00847946006549

Defibrillator ,MAIN,CCT,MAN-1,12 LEAD,SPO2,ETCO2,NIBP,IBP,TEMP,BIP,PACE,RCD,SMR,CDMK,AC,DMST
Zoll Medical Corporation
40021961100124010
In Commercial Distribution

  • 00847946006549 ()

  • 10.2" x 10.3" x 8.7"


  • Rechargeable professional automated external defibrillator

M SERIES CCT - 00847946006532

Defibrillator ,MAIN,CCT,MAN-1,12 LEAD,SPO2,ETCO2,NIBP,IBP,TEMP,BIP,PACE,RCD,SMR,CDMK,DC,DMST
Zoll Medical Corporation
40021921100124010
In Commercial Distribution

  • 00847946006532 ()

  • 10.2" x 10.3" x 8.7"


  • Rechargeable professional automated external defibrillator

M SERIES CCT - 00847946006525

Defibrillator ,MAIN,CCT,MAN-1,12 LEAD,SPO2,ETCO2,NIBP,IBP,TEMP,BIP,PACE,RCD,SMR,CDMK,AC,DMST,NELLCOR
Zoll Medical Corporation
40021911101124010
In Commercial Distribution

  • 00847946006525 ()

  • 10.2" x 10.3" x 8.7"


  • Rechargeable professional automated external defibrillator

M SERIES CCT - 00847946006518

Defibrillator ,MAIN,CCT,MAN-2,12 LEAD,SPO2,ETCO2,NIBP,IBP,TEMP,BIP,RCD,SMR,CDMK,NELLCOR,AC,DMST
Zoll Medical Corporation
40021911101024010
In Commercial Distribution

  • 00847946006518 ()

  • 10.2" x 10.3" x 8.7"


  • Rechargeable professional automated external defibrillator

M SERIES CCT - 00847946006501

Defibrillator ,MAIN,CCT,MAN-1,12 LEAD,SPO2,ETCO2,NIBP,IBP,TEMP,BIP,PACE,RCD,SMR,CDMK,AC,DMST
Zoll Medical Corporation
40021911100124010
In Commercial Distribution

  • 00847946006501 ()

  • 10.2" x 10.3" x 8.7"


  • Rechargeable professional automated external defibrillator

M SERIES CCT - 00847946006495

Defibrillator ,MAIN,CCT,MAN-2,12 LEAD,SPO2,ETCO2,NIBP,IBP,TEMP,BIP,RCD,SMR,CDMK,AC,DMST
Zoll Medical Corporation
40021911100024010
In Commercial Distribution

  • 00847946006495 ()

  • 10.2" x 10.3" x 8.7"


  • Rechargeable professional automated external defibrillator

M SERIES CCT - 00847946006488

Defibrillator ,MAIN,MAN-1,CCT,12 LEAD,SPO2,NIBP,IBP,TEMP,BIPHSC,PACE,NELLCOR,RCD,SMR,CDMK,AC,DMST
Zoll Medical Corporation
40021811101124010
In Commercial Distribution

  • 00847946006488 ()

  • 10.2" x 10.3" x 8.7"


  • Rechargeable professional automated external defibrillator

M SERIES CCT - 00847946006471

Defibrillator ,MAIN,MAN-1,CCT,12 LEAD,SPO2,NIBP,IBP,TEMP,BIPHSC,PACE,RCD,SMR,CDMK,AC,DMST
Zoll Medical Corporation
40021811100124010
In Commercial Distribution

  • 00847946006471 ()

  • 10.2" x 10.3" x 8.7"


  • Rechargeable professional automated external defibrillator

M SERIES CCT - 00847946006457

Defibrillator ,MAIN,CCT,MAN-1,12 LEAD,SPO2,ETCO2,NIBP,BIP,PACE,RCD,SMR,CDMK,AC,DMST
Zoll Medical Corporation
40021761100124010
In Commercial Distribution

  • 00847946006457 ()

  • 10.2" x 10.3" x 8.7"


  • Rechargeable professional automated external defibrillator

M SERIES CCT - 00847946004910

Defibrillator ,MAIN,CCT,MAN-1,3/5 LEAD,SPO2,ETCO2,NIBP,IBP,TEMP,BIPHSC,PACE,RCD,SMR,CDMK,AC,NELLCOR,DMST
Zoll Medical Corporation
40010961101124010
In Commercial Distribution

  • 00847946004910 ()

  • 10.2" x 10.3" x 8.7"


  • Rechargeable professional automated external defibrillator

M SERIES CCT - 00847946004897

Defibrillator ,MAIN,CCT,MAN-1,3/5 LEAD,SPO2,ETCO2,NIBP,IBP,TEMP,BIPHSC,PACE,RCD,SMR,CDMK,DC,DMST
Zoll Medical Corporation
40010921100124010
In Commercial Distribution

  • 00847946004897 ()

  • 10.2" x 10.3" x 8.7"


  • Rechargeable professional automated external defibrillator

M SERIES CCT - 00847946004873

Defibrillator ,MAIN,CCT,MAN-1,3/5 LEAD,SPO2,ETCO2,NIBP,IBP,TEMP,BIPHSC,PACE,RCD,SMR,CDMK,AC,DMST,NELLCOR
Zoll Medical Corporation
40010911101124010
In Commercial Distribution

  • 00847946004873 ()

  • 10.2" x 10.3" x 8.7"


  • Rechargeable professional automated external defibrillator

M SERIES CCT - 00847946004859

Defibrillator ,MAIN,CCT,MAN-1,3/5 LEAD,SPO2,ETCO2,NIBP,IBP,TEMP,BIPHSC,PACE,RCD,SMR,CDMK,AC,DMST
Zoll Medical Corporation
40010911100124010
In Commercial Distribution

  • 00847946004859 ()

  • 10.2" x 10.3" x 8.7"


  • Rechargeable professional automated external defibrillator

M SERIES CCT - 00847946004835

Defibrillator ,MAIN CCT,MAN-1,3/5 LEAD,SPO2,NIBP,IBP,TEMP,BIPHSC,PACE,RCD,SMR,CDMK,AC,DMST,NELLCOR
Zoll Medical Corporation
40010861101124010
In Commercial Distribution

  • 00847946004835 ()

  • 10.2" x 10.3" x 8.7"


  • Rechargeable professional automated external defibrillator
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