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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Contains DIs: E23504030; E23504040; E23504010; E23504020; E23502820; E23502850; E23502830; E23502860
SHOFU DENTAL CORPORATION
0308B
In Commercial Distribution

  • E2350308B0 ()
0308B

  • Dental abrasive point, reusable
AS-895 Columbia Blood Agar (CA) is intended for the isolation, quantitation, and partial identification of a variety of microorganisms, including fastidious organisms from clinical specimens. CA is suitable for use in antibiotic differential disk examination and spot biochemical testing. Pre-reduced anaerobically sterilized (PRAS). 100 x 15 mm agar plate. Opaque red. 4 plates per pack.
ANAEROBE SYSTEMS
AS-895
In Commercial Distribution

  • 00810048902354 ()
  • 00810048901166 ()
AS-895

  • Enriched agar culture medium IVD
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
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
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
BiPAP Pro, Canada
Respironics, Inc.
BiPAP Pro, CA
In Commercial Distribution

  • 00606959031371 ()
661CA

  • Home BPAP unit
Dorma 200, Canada
Respironics, Inc.
Dorma 200, CA
In Commercial Distribution

  • 00606959038578 ()
CAV201

  • Heated respiratory humidifier
  • Home CPAP unit
Dorma 200, Canada
Respironics, Inc.
Dorma 200, CA
In Commercial Distribution

  • 00606959038455 ()
201VCA

  • Home CPAP unit
  • Heated respiratory humidifier
BiPAP Auto, Canada
Respironics, Inc.
BiPAP Auto, CA
In Commercial Distribution

  • 00606959031715 ()
761CA

  • Home BPAP unit
REMstar Auto, Canada
Respironics, Inc.
REMstar Auto, CA
In Commercial Distribution

  • 00606959030527 ()
561CA

  • Home CPAP unit
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