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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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
RAPIDLyte Multicap blood collection capillary tubes (100 tubes) approx. volume 60µL. Each tube contains 130-200 I.U./mL Na+/Li+/Ca++ heparin, titrated with KCl. For capillary blood collection for the analysis of pH/ Blood Gas/Na+/K+/Ca++/Cl-/Glu/Lac/tHb.
Siemens Healthcare Diagnostics Inc.
10314213
In Commercial Distribution

  • 00630414108766 ()
  • 00630414009414 ()
473823

  • Capillary blood collection tube IVD, electrolyte-balanced heparin
Cosmetic Applicator Kit with GF (1 CA/pkg) - Includes a sterile, disposable cartridge tip, MicroGlide GF, and a disposable sleeve.
ECLIPSE
MP1002-CA-K1GF
Not in Commercial Distribution

  • 00853602008215 ()

  • Weight: 24.8 Gram
  • Depth: 1.000 Inch
  • Width: 2.000 Inch
  • Height: 4.500 Inch
MP1002-CA-K1GF

  • Cosmetic micro-needling electronic handpiece cartridge, professional
RAPIDLab® Na+/K+/Ca++/Cl- Electrode Fill Solution for in vitro diagnostic use on RAPIDLab® 348/348EX analyzers
Siemens Healthcare Diagnostics Inc.
10311047
In Commercial Distribution

  • 00630414194455 ()
  • 00630414010076 ()
478535

  • Multiple electrolyte IVD, kit, ion-selective electrode (ISE)
AN1004.01 EOGas 4 Refill Kit, CA, 16 EO 17.6g cartridges, 16 AN1087 Dosimeters, 16 Humidichips, 17 EOGas 4 sterilization bags
ANDERSEN STERILIZERS INC.
AN1004.01
In Commercial Distribution

  • 05060485030454 ()
AN1004.01

  • Ethylene oxide sterilizer
Series 1 400 DT trpl CA 1150 1000 850 9p Dual yk 30M 3P Dual yk 30M Gen 2 MH
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706007770 ()
C14T432531

  • Operating room light
Series 1 200 DT trpl CA 1150 1000 850 9p Dual yk 30M 3P Dual yk 30M Gen 2 MH
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706007350 ()
C12T432531

  • Operating room light
Series 1 300 DT trpl CA 1150 1000 850 9p Dual yk 30M 3P Dual yk 30M Gen 2 MH
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706001037 ()
C13T432531

  • Operating room light
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