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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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REUSABLE GEL PACK HOT OR COLD 6X10IN GLYCERINE CA 24 REUSABLE Not made with Natural Rubber Latex Halyard
OWENS & MINOR DISTRIBUTION, INC.
51780
In Commercial Distribution

  • 20885632413794 ()
  • 10885632413797 ()


  • Hot/cold therapy pack, reusable
Grounding Pad Split Cord Pediatric Multiple Green CA/100 Std Cord Not made with Natural Rubber Latex Halyard
OWENS & MINOR DISTRIBUTION, INC.
55555
In Commercial Distribution

  • 20885632412902 ()
  • 30885632412909 ()
  • 10885632412905 ()


  • Electrosurgical return electrode, single-use
Primary Dressing Wound Care Sterile Square Carboxymethylcellulose Off White CA/50 Not made with Natural Rubber Latex Halyard
OWENS & MINOR DISTRIBUTION, INC.
50094
In Commercial Distribution

  • 20885632403696 ()
  • 30885632403693 ()
  • 10885632403699 ()


  • Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
Primary Dressing Wound Care Sterile Rectangle Carboxymethylcellulose Off White CA/100 Not made with Natural Rubber Latex Halyard
OWENS & MINOR DISTRIBUTION, INC.
50093
In Commercial Distribution

  • 30885632403679 ()
  • 10885632403675 ()
  • 20885632403672 ()


  • Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
Primary Dressing Wound Care Sterile Square Carboxymethylcellulose Off White CA/100 Not made with Natural Rubber Latex Halyard
OWENS & MINOR DISTRIBUTION, INC.
50092
In Commercial Distribution

  • 30885632403662 ()
  • 10885632403668 ()
  • 20885632403665 ()


  • Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
IRRIGATION BOTTLE SODIUM CHLORIDE .9P 100ml PP CLEAR CA/48 STERILE NOT MADE WITH NATUAL RUBBER LATEX HALYARD
OWENS & MINOR DISTRIBUTION, INC.
49155
In Commercial Distribution

  • 20885632395946 ()
  • 10885632395949 ()


  • Non-antimicrobial wound irrigation solution, saline
IRRIGATION BOTTLE SODIUM CHLORIDE .9P 1000ml PP CLEAR CA/6 STERILE NOT MADE WITH NATUAL RUBBER LATEX HALYARD
OWENS & MINOR DISTRIBUTION, INC.
49154
In Commercial Distribution

  • 20885632395939 ()
  • 10885632395932 ()


  • Non-antimicrobial wound irrigation solution, saline
IRRIGATION BOTTLE SODIUM CHLORIDE .9P 500ml PP CLEAR CA/18 STERILE NOT MADE WITH NATUAL RUBBER LATEX HALYARD
OWENS & MINOR DISTRIBUTION, INC.
49153
In Commercial Distribution

  • 20885632395922 ()
  • 10885632395925 ()


  • Non-antimicrobial wound irrigation solution, saline
DreamStation CPAP Pro, Canada
Respironics, Inc.
DreamStation CPAP Pro, CA
In Commercial Distribution

  • 00606959026551 ()
CAX400S12

  • Home CPAP unit
BiPAP A40 Ventilator, Canada
Respironics, Inc.
BiPAP A40 Ventilator, CA
In Commercial Distribution

  • 00606959039506 ()
1111173

  • Portable electric ventilator
BiPAP A30 Ventilator, Canada
Respironics, Inc.
BiPAP A30 Ventilator, CA
In Commercial Distribution

  • 00606959039339 ()
1111147

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

  • 00606959031418 ()
661CABT

  • 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
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
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
S1 500 DT Dual CA 1150 1000 (Nml 3P SA, Dl Yoke 3P Lit) (Nl 3P SA, 3P Light)
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706007657 ()
C15D4333

  • Operating room light
S1 200 DT Dual CA 1150mm 1000mm (Nml 3P SA Dual YK 3P LT) Sgl MH - Sony Cvrt/Int
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706007633 ()
C12D433N

  • Operating room light
S1 300 DT Dual CA 1150mm 1000mm (Nml 9P SA Dual YK 9P LT) Sgl MH - Sony Cvrt/Int
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706007626 ()
C13D435N

  • Operating room light
S3 300 DT Dual CA 1000mm 850mm (Norm 3P SA Dl YK 3P LT)Sgl MH for Sony Mon.
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706007534 ()
C33BDB323M

  • Operating room light
Series 1 300 DT Triple CA 1150 1000 850 Gen 1 3p sngl yoke x2 sngl M SA MH
Amico Clinical Solutions Corp
iCE30
In Commercial Distribution

  • 00684706001013 ()
C13T432FF1

  • Operating room light
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