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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 Pro C-Flex+, with Heated Tube Humidifier, System One 60 Series, Canada
Respironics, Inc.
00
In Commercial Distribution

  • 00606959014084 ()
CA461HS

  • Home CPAP unit
REMstar Auto System One 60 series CPAP System with Heated Tube Humidifier and Bluetooth (American Home Patient unit)
Respironics, Inc.
00
In Commercial Distribution

  • 00606959023932 ()
AH560TBT

  • Home CPAP unit
REMstar Pro C-Flex+, with Heated Tube Humidifier, System One 60 Series, China
Respironics, Inc.
REMstar Pro C-Flex+, w/HT Humid System One 60 Series CN
Not in Commercial Distribution

  • 00606959015128 ()
CN467TS

  • Home CPAP unit
BiPAP Auto BiFlex with Humidifier, System One 60 Series, International
Respironics, Inc.
BiPAP Auto BiFlex, w/Humid System One 60 Series INT
In Commercial Distribution

  • 00606959031548 ()
IN761HS

  • Home BPAP unit
BiPAP Pro BiFlex with Heated Tube Humidifier, Standard Tube, 60 Series, Canada
Respironics, Inc.
BiPAP Pro BiFlex, w/H Tube Hum, with St Tube, 60 Series, CA
In Commercial Distribution

  • 00606959031401 ()
CA661NTS

  • Home BPAP unit
REMstar Plus, International
Respironics, Inc.
REMstar Plus, INTL
In Commercial Distribution

  • 00606959028654 ()
261P

  • Home CPAP unit
REMstar Plus, USA
Respironics, Inc.
REMstar Plus, US
In Commercial Distribution

  • 00606959028647 ()
260P

  • Home CPAP unit
Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood glucose. Kit contains: CONTOUR® NEXT ONE blood glucose meter; 10 CONTOUR® NEXT blood glucose test strips; Lancing Device; 10 Colored MICROLET® lancets (provided sterile); User Guide (including CONTOUR® DIABETES app download instructions); Quick Reference Guide; Carrying Case; Web Registration / Warranty Card; CONTOUR® NEXT control solution. A clear endcap is available for Alternative Site Testing (AST). It may not be included in your meter kit. If you perform AST and need a clear endcap (for palm), contact Diabetes Care Customer Service.
ASCENSIA DIABETES CARE US INC.
9767
Not in Commercial Distribution

  • 40301939767018 ()
  • 00301939767010 ()
  • 0193-9767-01 ()
85977059

  • Glucose monitoring system IVD, home-use
Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood glucose. Kit contains: CONTOUR® NEXT ONE Meter; Lancing Device; 10 MICROLET® Colored Lancets (provided sterile); User Guide (including CONTOUR DIABETES app download instructions); Quick Reference Guide; Carrying Case; Web Registration / Warranty Card; CONTOUR® NEXT Control Solution.
ASCENSIA DIABETES CARE US INC.
9765
In Commercial Distribution

  • 40301939765014 ()
  • 00301939765016 ()
  • 0193-9765-01 ()
85602314

  • Glucose monitoring system IVD, home-use
Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood glucose. Kit contains: CONTOUR® NEXT ONE Meter; 10 CONTOUR® NEXT Blood Glucose Test Strips; Lancing Device; 10 MICROLET® Colored Lancets (provided sterile); User Guide (including CONTOUR DIABETES app download instructions); Quick Reference Guide; Carrying Case; Web Registration / Warranty Card; CONTOUR® NEXT Control Solution.
ASCENSIA DIABETES CARE US INC.
9763
Not in Commercial Distribution

  • 40301939763010 ()
  • 00301939763012 ()
  • 0193-9763-01 ()
85012088

  • Glucose monitoring system IVD, home-use
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