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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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REMstar System One 60 Series - 00606959030046

REMstar Plus, Canada
Respironics, Inc.
REMstar Plus, CA
In Commercial Distribution

  • 00606959030046 ()
261CA

  • Home CPAP unit

Dorma 200 - 00606959038578

Dorma 200, Canada
Respironics, Inc.
Dorma 200, CA
In Commercial Distribution

  • 00606959038578 ()
CAV201

  • Heated respiratory humidifier
  • Home CPAP unit

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

PHOENIX DIAGNOSTICS, INC. - 00853366007585

ISE Cal Pack (Snap Pack) for Medica Na/K/Ca/pH EasyLyte Electrolyte Systems
PHOENIX DIAGNOSTICS, INC.
19-006
In Commercial Distribution

  • 00853366007585 ()


  • Multiple electrolyte IVD, calibrator

iCE Surgical Light - 00684706007831

Series 1, 300 DT, Single CA, 850mm, (LCH 9P SA, Single yoke, 9P Light)
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706007831 ()
C13S26

  • Operating room light

iCE Surgical Light - 00684706007800

Series 1, 400 DT, Single CA, 1150mm, (Normal 3P SA, Dual yoke, 3P Light),
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706007800 ()
C14S43

  • Operating room light

iCE Surgical Light - 00684706007763

Series 1, 500 DT, Single CA, 1450mm, (LCH 3P SA, Single yoke, 3P Light)
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706007763 ()
C15S64

  • Operating room light

iCE Surgical Light - 00684706007510

Series 1, 200 DT, Single CA, 1600mm, (LCH 9P SA, Single yoke, 9P Light)
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706007510 ()
C12S76

  • Operating room light
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