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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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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 - 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

Lifecard - 10841522127144

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

  • 10841522127144 ()
LCF

  • Electrocardiographic ambulatory recorder

Lifecard - 10841522127137

LIFECARD CF, 4 LEAD, HOLTER RECORDER
SPACELABS HEALTHCARE (WASHINGTON), INC
Lifecard
Not in Commercial Distribution

  • 10841522127137 ()
LCF4L

  • 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

SEER 1000 - 04250903202650

The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by itself and is in-tended to be used with an ECG analysis software package. The recorded data are downloaded to a PC for analysis and subsequent evaluation by a trained physician or healthcare professional.
getemed Medizin- und Informationstechnik AG
7 day - Japanese
In Commercial Distribution

  • 04250903202650 ()
2067634-063

  • Electrocardiographic ambulatory recorder

SEER 1000 - 04250903202643

The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by itself and is in-tended to be used with an ECG analysis software package. The recorded data are downloaded to a PC for analysis and subsequent evaluation by a trained physician or healthcare professional.
getemed Medizin- und Informationstechnik AG
48 hour - Japanese
In Commercial Distribution

  • 04250903202643 ()
2067634-062

  • Electrocardiographic ambulatory recorder

SEER 1000 - 04250903202636

The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by itself and is in-tended to be used with an ECG analysis software package. The recorded data are downloaded to a PC for analysis and subsequent evaluation by a trained physician or healthcare professional.
getemed Medizin- und Informationstechnik AG
24 hour - Japanese
In Commercial Distribution

  • 04250903202636 ()
2067634-061

  • Electrocardiographic ambulatory recorder

SEER 1000 Apple App - 04250903201202

The SEER 1000 Apple App is a software product which is an accessory to the SEER 1000 recorder. The SEER 1000 Apple App assists in the hook-up procedure (e.g. displaying of ECG data and setting of patient demographic data).
getemed Medizin- und Informationstechnik AG
V1.2.1
In Commercial Distribution

  • 04250903201202 ()
2067634-056

  • Electrocardiographic ambulatory recorder

SEER 1000 PC App - 04250903201196

The SEER 1000 PC App is a software product which is an accessory to the SEER 1000 recorder. The SEER 1000 PC App assists in the hook-up procedure (e.g. displaying of ECG data and setting of patient demographic data).
getemed Medizin- und Informationstechnik AG
V1.0SP03
In Commercial Distribution

  • 04250903201196 ()
2067634-055

  • Electrocardiographic ambulatory recorder

SEER 1000 - 04250903201127

The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by itself and is in-tended to be used with an ECG analysis software package. The recorded data are downloaded to a PC for analysis and subsequent evaluation by a trained physician or healthcare professional.
getemed Medizin- und Informationstechnik AG
7 day - CA
In Commercial Distribution

  • 04250903201127 ()
2067634-177

  • Electrocardiographic ambulatory recorder

SEER 1000 - 04250903201103

The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by itself and is in-tended to be used with an ECG analysis software package. The recorded data are downloaded to a PC for analysis and subsequent evaluation by a trained physician or healthcare professional.
getemed Medizin- und Informationstechnik AG
48 hour - CA
In Commercial Distribution

  • 04250903201103 ()
2067634-176

  • Electrocardiographic ambulatory recorder

SEER 1000 - 04250903201080

The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by itself and is in-tended to be used with an ECG analysis software package. The recorded data are downloaded to a PC for analysis and subsequent evaluation by a trained physician or healthcare professional.
getemed Medizin- und Informationstechnik AG
24 hour - CA
In Commercial Distribution

  • 04250903201080 ()
2067634-175

  • Electrocardiographic ambulatory recorder

SEER 1000 - 04250903201035

The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by itself and is in-tended to be used with an ECG analysis software package. The recorded data are downloaded to a PC for analysis and subsequent evaluation by a trained physician or healthcare professional.
getemed Medizin- und Informationstechnik AG
7 Day - Korean
In Commercial Distribution

  • 04250903201035 ()
2067634-069

  • Electrocardiographic ambulatory recorder

SEER 1000 - 04250903201011

The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by itself and is in-tended to be used with an ECG analysis software package. The recorded data are downloaded to a PC for analysis and subsequent evaluation by a trained physician or healthcare professional.
getemed Medizin- und Informationstechnik AG
48 Hour - Korean
In Commercial Distribution

  • 04250903201011 ()
2067634-068

  • Electrocardiographic ambulatory recorder

SEER 1000 - 04250903200991

The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by itself and is in-tended to be used with an ECG analysis software package. The recorded data are downloaded to a PC for analysis and subsequent evaluation by a trained physician or healthcare professional.
getemed Medizin- und Informationstechnik AG
24 Hour - Korean
In Commercial Distribution

  • 04250903200991 ()
2067634-067

  • Electrocardiographic ambulatory recorder

SEER 1000 - 04250903200915

The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by itself and is in-tended to be used with an ECG analysis software package. The recorded data are downloaded to a PC for analysis and subsequent evaluation by a trained physician or healthcare professional.
getemed Medizin- und Informationstechnik AG
7 day - UNI
In Commercial Distribution

  • 04250903200915 ()
2067634-060

  • Electrocardiographic ambulatory recorder

SEER 1000 - 04250903200892

The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by itself and is in-tended to be used with an ECG analysis software package. The recorded data are downloaded to a PC for analysis and subsequent evaluation by a trained physician or healthcare professional.
getemed Medizin- und Informationstechnik AG
48 hour - UNI
In Commercial Distribution

  • 04250903200892 ()
2067634-059

  • Electrocardiographic ambulatory recorder

SEER 1000 - 04250903200878

The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by itself and is in-tended to be used with an ECG analysis software package. The recorded data are downloaded to a PC for analysis and subsequent evaluation by a trained physician or healthcare professional.
getemed Medizin- und Informationstechnik AG
24 hour - UNI
In Commercial Distribution

  • 04250903200878 ()
2067634-058

  • Electrocardiographic ambulatory recorder

SEER 1000 - 04250903200748

The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by itself and is in-tended to be used with an ECG analysis software package. The recorded data are downloaded to a PC for analysis and subsequent evaluation by a trained physician or healthcare professional.
getemed Medizin- und Informationstechnik AG
7 day - Korean
Not in Commercial Distribution

  • 04250903200748 ()
2067634-069

  • Electrocardiographic ambulatory recorder

SEER 1000 - 04250903200731

The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by itself and is in-tended to be used with an ECG analysis software package. The recorded data are downloaded to a PC for analysis and subsequent evaluation by a trained physician or healthcare professional.
getemed Medizin- und Informationstechnik AG
48 hour - Korean
Not in Commercial Distribution

  • 04250903200731 ()
2067634-068

  • Electrocardiographic ambulatory recorder

SEER 1000 - 04250903200724

The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by itself and is in-tended to be used with an ECG analysis software package. The recorded data are downloaded to a PC for analysis and subsequent evaluation by a trained physician or healthcare professional.
getemed Medizin- und Informationstechnik AG
24 hour - Korean
Not in Commercial Distribution

  • 04250903200724 ()
2067634-067

  • Electrocardiographic ambulatory recorder

Microlife - 04719003932053

No Description
MICROLIFE USA, INC.
CUFFM-WBPOANKLE
In Commercial Distribution

  • 14719003932050 ()
  • 04719003932053 ()


  • Arrythmia-detection sphygmomanometer

Microlife - 04719003631284

No Description
MICROLIFE USA, INC.
BP3SZ1-1AFIB
In Commercial Distribution

  • 14719003631281 ()
  • 04719003631284 ()


  • Arrythmia-detection blood pressure ambulatory recorder

Microlife - 04719003315085

WBP Home A BT (BP3MX1-3C) with Universal Label for USA/EU/CA markets
MICROLIFE USA, INC.
CRO-BP3MX1-3C1
In Commercial Distribution

  • 04719003315085 ()
  • 14719003315082 ()
  • 24719003315089 ()
  • 34719003315086 ()


  • Arrythmia-detection sphygmomanometer

Microlife - 04719003315047

WatchBP O3 2G(BP3SZ1-1) CBP type
MICROLIFE USA, INC.
BP3SZ1-1CEN
In Commercial Distribution

  • 14719003315044 ()
  • 04719003315047 ()
  • 24719003315041 ()
WatchBP O3 2G

  • Arrythmia-detection blood pressure ambulatory recorder
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