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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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Lifecard - 10841522125348

LIFECARD CF 12 REC EU
SPACELABS HEALTHCARE (WASHINGTON), INC
Lifecard
Not in Commercial Distribution

  • 10841522125348 ()
LC12

  • Electrocardiographic ambulatory recorder

Spacelabs Healthcare - 10841522125171

LIFECARD CF,DEVICE
SPACELABS HEALTHCARE (WASHINGTON), INC
LCF
Not in Commercial Distribution

  • 10841522125171 ()
46-0061

  • Electrocardiographic ambulatory recorder

EVO - 10841522125164

EVO RECORDER,DEVICE
SPACELABS HEALTHCARE (WASHINGTON), INC
TAY
Not in Commercial Distribution

  • 10841522125164 ()
50-0018

  • Electrocardiographic ambulatory recorder

Spacelabs Healthcare - 10841522125140

4 ELECTRODE EVO RECORDER BELT MOUNTED
SPACELABS HEALTHCARE (WASHINGTON), INC
TAY
Not in Commercial Distribution

  • 10841522125140 ()
50-0035

  • Electrocardiographic ambulatory recorder

Spacelabs Healthcare - 10841522125133

4 ELECTRODE EVO RECORDER PACKED
SPACELABS HEALTHCARE (WASHINGTON), INC
TAY
Not in Commercial Distribution

  • 10841522125133 ()
50-0034

  • Electrocardiographic ambulatory recorder

Spacelabs Healthcare - 10841522124969

4 ELECTRODE EVO RECORDER BELT MOUNTED, DANISH
SPACELABS HEALTHCARE (WASHINGTON), INC
TAY
Not in Commercial Distribution

  • 10841522124969 ()
50-0035-15

  • Electrocardiographic ambulatory recorder

Spacelabs Healthcare - 10841522124952

4 ELECTRODE EVO RECORDER BELT MOUNTED, RUSSIAN
SPACELABS HEALTHCARE (WASHINGTON), INC
TAY
Not in Commercial Distribution

  • 10841522124952 ()
50-0035-12

  • Electrocardiographic ambulatory recorder

Spacelabs Healthcare - 10841522124945

4 ELECTRODE EVO RECORDER BELT MOUNTED, DUTCH
SPACELABS HEALTHCARE (WASHINGTON), INC
TAY
Not in Commercial Distribution

  • 10841522124945 ()
50-0035-09

  • Electrocardiographic ambulatory recorder

Spacelabs Healthcare - 10841522124938

4 ELECTRODE EVO RECORDER BELT MOUNTED, BR PORTUG
SPACELABS HEALTHCARE (WASHINGTON), INC
TAY
Not in Commercial Distribution

  • 10841522124938 ()
50-0035-08

  • Electrocardiographic ambulatory recorder

Spacelabs Healthcare - 10841522124921

4 ELECTRODE EVO RECORDER BELT MOUNTED, POLISH
SPACELABS HEALTHCARE (WASHINGTON), INC
TAY
Not in Commercial Distribution

  • 10841522124921 ()
50-0035-07

  • Electrocardiographic ambulatory recorder

Spacelabs Healthcare - 10841522124914

4 ELECTRODE EVO, BELT MOUNTED, PACKED, SWEDISH
SPACELABS HEALTHCARE (WASHINGTON), INC
TAY
Not in Commercial Distribution

  • 10841522124914 ()
50-0035-06

  • Electrocardiographic ambulatory recorder

Spacelabs Healthcare - 10841522124907

4 ELECTRODE EVO, BELT MOUNTED, PACKED, SPANISH
SPACELABS HEALTHCARE (WASHINGTON), INC
TAY
Not in Commercial Distribution

  • 10841522124907 ()
50-0035-05

  • Electrocardiographic ambulatory recorder

Spacelabs Healthcare - 10841522124891

4 ELECTRODE EVO, BELT MOUNTED, PACKED ITALIAN
SPACELABS HEALTHCARE (WASHINGTON), INC
TAY
Not in Commercial Distribution

  • 10841522124891 ()
50-0035-04

  • Electrocardiographic ambulatory recorder

Spacelabs Healthcare - 10841522124884

4 ELECTRODE EVO, BELT MOUNTED, PACKED, FRENCH
SPACELABS HEALTHCARE (WASHINGTON), INC
TAY
Not in Commercial Distribution

  • 10841522124884 ()
50-0035-03

  • Electrocardiographic ambulatory recorder

Spacelabs Healthcare - 10841522124877

4 ELECTRODE EVO BELT MOUNTED, PACKED, GERMAN
SPACELABS HEALTHCARE (WASHINGTON), INC
TAY
Not in Commercial Distribution

  • 10841522124877 ()
50-0035-02

  • Electrocardiographic ambulatory recorder

Spacelabs Healthcare - 10841522124860

4 ELECTRODE EVO RECORDER PACKED, DANISH
SPACELABS HEALTHCARE (WASHINGTON), INC
TAY
Not in Commercial Distribution

  • 10841522124860 ()
50-0034-15

  • Electrocardiographic ambulatory recorder

Spacelabs Healthcare - 10841522124853

4 ELECTRODE EVO RECORDER PACKED, RUSSIAN
SPACELABS HEALTHCARE (WASHINGTON), INC
TAY
Not in Commercial Distribution

  • 10841522124853 ()
50-0034-12

  • Electrocardiographic ambulatory recorder

Spacelabs Healthcare - 10841522124846

4 ELECTRODE EVO RECORDER PACKED, DUTCH
SPACELABS HEALTHCARE (WASHINGTON), INC
TAY
Not in Commercial Distribution

  • 10841522124846 ()
50-0034-09

  • Electrocardiographic ambulatory recorder

Spacelabs Healthcare - 10841522124839

4 ELECTRODE EVO RECORDER PACKED, BR PORTUGUESE
SPACELABS HEALTHCARE (WASHINGTON), INC
TAY
Not in Commercial Distribution

  • 10841522124839 ()
50-0034-08

  • Electrocardiographic ambulatory recorder

Spacelabs Healthcare - 10841522124822

4 ELECTRODE EVO RECORDER PACKED, POLISH
SPACELABS HEALTHCARE (WASHINGTON), INC
TAY
Not in Commercial Distribution

  • 10841522124822 ()
50-0034-07

  • Electrocardiographic ambulatory recorder

Spacelabs Healthcare - 10841522124815

4 ELECTRODE EVO RECORDER, PACKED, SWEDISH
SPACELABS HEALTHCARE (WASHINGTON), INC
TAY
Not in Commercial Distribution

  • 10841522124815 ()
50-0034-06

  • Electrocardiographic ambulatory recorder

Spacelabs Healthcare - 10841522124808

4 ELECTRODE EVO RECORDER, PACKED, SPANISH
SPACELABS HEALTHCARE (WASHINGTON), INC
TAY
Not in Commercial Distribution

  • 10841522124808 ()
50-0034-05

  • Electrocardiographic ambulatory recorder

Spacelabs Healthcare - 10841522124792

4 ELECTRODE EVO RECORDER, PACKED, ITALIAN
SPACELABS HEALTHCARE (WASHINGTON), INC
TAY
Not in Commercial Distribution

  • 10841522124792 ()
50-0034-04

  • Electrocardiographic ambulatory recorder

Spacelabs Healthcare - 10841522124785

4 ELECTRODE EVO RECORDER PACKED, FRENCH
SPACELABS HEALTHCARE (WASHINGTON), INC
TAY
Not in Commercial Distribution

  • 10841522124785 ()
50-0034-03

  • Electrocardiographic ambulatory recorder

Spacelabs Healthcare - 10841522124778

4 ELECTRODE EVO RECORDER, PACKED, GERMAN
SPACELABS HEALTHCARE (WASHINGTON), INC
TAY
Not in Commercial Distribution

  • 10841522124778 ()
50-0034-02

  • Electrocardiographic ambulatory recorder

Spacelabs Healthcare - 10841522123962

EVO DOCKING STATION USB CONN & UK CBL
SPACELABS HEALTHCARE (WASHINGTON), INC
TAY
Not in Commercial Distribution

  • 10841522123962 ()
50-0169

  • Electrocardiographic ambulatory recorder

Spacelabs Healthcare - 10841522123924

LIFECARD CF 12 REC EU
SPACELABS HEALTHCARE (WASHINGTON), INC
LCF
Not in Commercial Distribution

  • 10841522123924 ()
LC12

  • Electrocardiographic ambulatory recorder

Spacelabs Healthcare - 10841522123894

LIFECARD CF DIGITAL HOLTER MON
SPACELABS HEALTHCARE (WASHINGTON), INC
LCF
Not in Commercial Distribution

  • 10841522123894 ()
LCF

  • Electrocardiographic ambulatory recorder

SPACELABS HEALTHCARE - 10841522123047

KIT,HOOK-UP,ARIA,C/W POUCH
SPACELABS HEALTHCARE (WASHINGTON), INC
ARIA; SUPPLY
In Commercial Distribution

  • 10841522123047 ()
23189-106

  • Electrocardiographic ambulatory recorder

Spacelabs Healthcare - 10841522121821

LIFECARD CF FINAL ASSY
SPACELABS HEALTHCARE (WASHINGTON), INC
LCF
Not in Commercial Distribution

  • 10841522121821 ()
46-0061-UDI

  • Electrocardiographic ambulatory recorder

Spacelabs Healthcare - 10841522120183

ELECT SNP LD SET,18" WHT/BLK/RED/GRN/ORN/BLU/BRN
SPACELABS HEALTHCARE (WASHINGTON), INC
25452-519
Not in Commercial Distribution

  • 10841522120183 ()
N/A

  • Electrocardiographic ambulatory recorder

Spacelabs Healthcare - 10841522107962

LIFECARD CF 12 REC US
SPACELABS HEALTHCARE (WASHINGTON), INC
LCF
Not in Commercial Distribution

  • 10841522107962 ()
LC12US

  • Electrocardiographic ambulatory recorder

Spacelabs Healthcare - 10841522107931

LIFECARD CF 12 REC EU
SPACELABS HEALTHCARE (WASHINGTON), INC
LCF
Not in Commercial Distribution

  • 10841522107931 ()
LC12

  • Electrocardiographic ambulatory recorder

Spacelabs Healthcare - 10841522103391

EVO DOCKING STATION USB CONN & US CBL
SPACELABS HEALTHCARE (WASHINGTON), INC
TAY
Not in Commercial Distribution

  • 10841522103391 ()
50-0045

  • Electrocardiographic ambulatory recorder

Spacelabs Healthcare - 10841522103384

EVO DOCKING STATION USB CONN & EU PWR CBL
SPACELABS HEALTHCARE (WASHINGTON), INC
TAY
Not in Commercial Distribution

  • 10841522103384 ()
50-0044

  • Electrocardiographic ambulatory recorder

Spacelabs Healthcare - 10841522103377

4 ELECTRODE EVO RECORDER PACKED
SPACELABS HEALTHCARE (WASHINGTON), INC
TAY
Not in Commercial Distribution

  • 10841522103377 ()
50-0034

  • Electrocardiographic ambulatory recorder

AXIR-CX - 08800099500076

Radiological Image Processing System
Radisen Co., Ltd.
AXIR-CX
In Commercial Distribution

  • 08800099500076 ()
AXIR-CX

  • Diagnostic x-ray digital imaging system workstation

Carnation Ambulatory Monitor - 30851398007017

No Description
BARDY DIAGNOSTICS, INC.
B1000R2000
In Commercial Distribution

  • 30851398007017 ()


  • Electrocardiographic ambulatory recorder

SPACELABS HEALTHCARE - 30841522123041

KIT,HOOK-UP,CASE OF 20,ARIA
SPACELABS HEALTHCARE (WASHINGTON), INC
ARIA; SUPPLY
In Commercial Distribution

  • 30841522123041 ()
23189-106-401

  • Electrocardiographic ambulatory recorder

Carnation Ambulatory Monitor - 40851398007014

No Description
BARDY DIAGNOSTICS, INC.
B1000R1400
In Commercial Distribution

  • 40851398007014 ()


  • Electrocardiographic ambulatory recorder
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