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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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LENS-MATE CONTACT LENS CASES
COMPASS HEALTH BRANDS CORP.
71016
In Commercial Distribution

  • 00076855710166 ()
  • 30076855710167 ()
  • 10076855710217 ()
  • 40076855710164 ()


  • Contact lens case
DIGITAL THERM W/FLEX TIP BOXED
COMPASS HEALTH BRANDS CORP.
70061B
In Commercial Distribution

  • 40076855700615 ()
  • 00076855700617 ()
  • 30076855700618 ()


  • Intermittent electronic patient thermometer
DIGITAL PACIFIER THERMOMETER
COMPASS HEALTH BRANDS CORP.
70040
In Commercial Distribution

  • 40076855700400 ()
  • 00076855700402 ()
  • 30076855700403 ()


  • Intermittent electronic patient thermometer
Electrocardiographic recording paper
GRAPHIC CONTROLS ACQUISITION CORP
HP M1911A (40/CA)
In Commercial Distribution

  • 50009336000598 ()
  • 00009336000593 ()
32016831

  • Electrocardiographic recording paper
Electrocardiographic recording paper
GRAPHIC CONTROLS ACQUISITION CORP
HP M1707A (8/CA)
In Commercial Distribution

  • 50009336000529 ()
  • 00009336000524 ()
30768678

  • Electrocardiographic recording paper
Electrocardiographic recording paper
GRAPHIC CONTROLS ACQUISITION CORP
CMS 4305 (40/CA)
In Commercial Distribution

  • 50009336000130 ()
  • 00009336000135 ()
30597226

  • Electrocardiographic recording paper
BiPAP A40 Ventilator, Canada
Respironics, Inc.
BiPAP A40 Ventilator, CA
In Commercial Distribution

  • 00606959039506 ()
1111173

  • Portable electric ventilator
Dorma 500 Auto, Canada
Respironics, Inc.
Dorma 500 Auto, CA
In Commercial Distribution

  • 00606959038509 ()
501VCA

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

  • 00606959038417 ()
521CA

  • Home CPAP unit
  • Heated respiratory humidifier
Bluetooth Accessory Module, Canada
Respironics, Inc.
Bluetooth Accessory Module, CA
Not in Commercial Distribution

  • 00606959005136 ()
100210B

  • Clinical laboratory information system
The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory environment. The ROTEM® delta is intended to be used to provide a qualitative and quantitative indication of the coagulation state of a blood sample. For this purpose the ROTEM® delta records the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and lyses in real time. The analyzer output consists of a qualitative graphical representation (mirrored coagulation curve - clot firmness over time) and several defined numerical parameters describing the curve quantitatively.
Tem Innovations GmbH
delta System (US/CA)
In Commercial Distribution

  • 04260160470587 ()
201001

  • Coagulation analyser IVD, laboratory, semi-automated
Dorma 500 Auto, Canada
Respironics, Inc.
Dorma 500 Auto, CA
In Commercial Distribution

  • 00606959036734 ()
CAV501

  • Heated respiratory humidifier
  • Home CPAP unit
Millennium M10 Concentrator, Canada
Respironics, Inc.
Millennium M10 Concentrator, CA
In Commercial Distribution

  • 00606959033184 ()
M10600-80

  • Stationary oxygen concentrator
BiPAP Auto, BlueTooth, Canada
Respironics, Inc.
BiPAP Auto BlueTooth, CA
In Commercial Distribution

  • 00606959031753 ()
761CABT

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

  • 00606959026643 ()
CAX700S12

  • Home BPAP unit
DreamStation BiPAP Pro, Canada
Respironics, Inc.
DreamStation BiPAP Pro, CA
In Commercial Distribution

  • 00606959026612 ()
CAX600S12

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

  • 00606959026582 ()
CAX500S12

  • Home CPAP unit
DreamStation CPAP Pro, Canada
Respironics, Inc.
DreamStation CPAP Pro, CA
In Commercial Distribution

  • 00606959026551 ()
CAX400S12

  • Home CPAP unit
BiPAP Pro, Bluetooth, Canada
Respironics, Inc.
BiPAP Pro, Bluetooth, CA
In Commercial Distribution

  • 00606959031418 ()
661CABT

  • Home BPAP unit
BiPAP A30 Ventilator, Canada
Respironics, Inc.
BiPAP A30 Ventilator, CA
In Commercial Distribution

  • 00606959039339 ()
1111147

  • Portable electric ventilator
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