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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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syngo X Workplace - 04056869010113

No Description
Siemens Healthcare GmbH
10502522
In Commercial Distribution

  • 04056869010113 ()


  • Diagnostic x-ray digital imaging system workstation

Digital Expert Access - 00195278263919

DE Modality Connectivity Executable
GE HEALTHCARE
1
In Commercial Distribution

  • 00195278263919 ()


  • Diagnostic x-ray digital imaging system workstation

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

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

coDiagnostiX - D835CODX1

Dental surgery treatment planning software
Dental Wings GmbH
10
In Commercial Distribution

  • D835CODX200 ()
  • D835CODX1 ()
  • D835CODX201 ()
  • D835CODX202 ()


  • Diagnostic x-ray digital imaging system workstation

coDiagnostiX - D835CDX1

Dental implant planning software
Dental Wings GmbH
9
Not in Commercial Distribution

  • D835CDX202 ()
  • D835CDX1 ()
  • D835CDX201 ()
  • D835CDX200 ()


  • Diagnostic x-ray digital imaging system workstation

Midmark Digital ECG - 00841709121319

Midmark Digital ECG from Midmark is an easy-to-use, digital, 12-lead resting ECG solution that helps you quickly administer testing and access patient test results you need to make informed cardiac assessments and provide more efficient patient care. Kit includes Midmark Digital ECG device - USB version, 10-Lead Patient Cable, 10-Pack Clear ECG Clips, and 100-Pack Disposable ECG Electrodes, Device silicon cover.
MIDMARK CORPORATION
4-000-0080
In Commercial Distribution

  • 00841709121319 ()
4-000-0080

  • Electrocardiographic ambulatory recorder

Arial - 00840948100963

Arial Mobile App
Securitas Healthcare LLC
54600
In Commercial Distribution

  • 00840948100963 ()


  • Alarm application software

Arial - 00840948100840

Arial Software
Securitas Healthcare LLC
54302
In Commercial Distribution

  • 00840948100840 ()


  • Alarm application software

Holter Prep Kit - 10812345026020

Holter prep kit with AAA battery cleared with H3+ Holter recorder
MORTARA INSTRUMENT, INC.
XKTHOLT5LA
Not in Commercial Distribution

  • 30812345026024 ()
  • 20812345026027 ()
  • 10812345026020 ()


  • Electrocardiographic ambulatory recorder

EndoFLIP - 10884521809420

Endolumenal Functional Lumen Imaging Probe
Covidien LP
EF-325N
In Commercial Distribution

  • 20884521809427 ()
  • 10884521809420 ()
  • 30884521809424 ()


  • Manometric gastrointestinal motility analysis system

EndoFLIP - 10884521809413

Endolumenal Functional Lumen Imaging Probe
Covidien LP
EF-322N
In Commercial Distribution

  • 20884521809410 ()
  • 10884521809413 ()
  • 30884521809417 ()


  • Manometric gastrointestinal motility analysis system

EndoFLIP - 10884521809376

LK-103 ENDOFLIP LOCALIZATION KIT US
Covidien LP
LK-103
In Commercial Distribution

  • 10884521809376 ()


  • Manometric gastrointestinal motility analysis system

EndoFLIP - 10884521809321

PRE USE CHECK KIT LK-200 FLIP
Covidien LP
LK-200
In Commercial Distribution

  • 10884521809321 ()


  • Manometric gastrointestinal motility analysis system

EndoFLIP - 10884521809314

TOPOGRAPHY SYSTEM DD-961
Covidien LP
DD-961
In Commercial Distribution

  • 10884521809314 ()


  • Manometric gastrointestinal motility analysis system
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