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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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Overall size 24”W x 20.5”D x 64.75”T. 7.45 Cubic ft. storage Upper Chamber I.D. 20”W x 17”D x 13.5”T 2.65 Cubic ft. storage Temperature Range: 90-160 F Accuracy +/- 1 degrees F of set point Lower Chamber I.D. 20”W x 17”D x 24.5”T 4.8 Cubic ft. storage Temperature Range: 90-160 F Accuracy +/- 2 degrees F of set point 3 Adjustable shelves Digital control Stainless steel doors Data logger Locking upper chamber Key Temperature lock Audible and visual over-temp alarm Foot levelers 4" base Recessed w/ no top or sides Electrical: 120V, 7.5 Amp, 50/60 Hz .49 kw/hr, 1678 btu/hr UL/CUL listed FDA Registered
M.A.C. MEDICAL INC.
DWC182464T-4B-R1
In Commercial Distribution

  • B286DWC182464T4BR11 ()
DWC182464T-4B-R1

  • Blanket warming cabinet, dry-heat
Accessory to the 1230 3D SCANNER used to measure the Tissue Phantom Ratio.
SUN NUCLEAR CORP.
1230000-4Z
In Commercial Distribution

1230000-4Z

  • Accelerator system quality assurance device
Radiation Therapy QA Device. For use with the 1230 3D SCANNER.
SUN NUCLEAR CORP.
1203300Z
In Commercial Distribution

12300009Z

  • Accelerator system quality assurance device
Accessory to the 1230 3D SCANNER used to measure the Tissue Phantom Ratio
SUN NUCLEAR CORP.
1230680Z
Not in Commercial Distribution

1230000-4Z

  • Accelerator system quality assurance device
Radiation Therapy QA Device. For use with the 1230 3D SCANNER.
SUN NUCLEAR CORP.
12300009Z
In Commercial Distribution

  • B01612300009Z0 ()
12300009Z

  • Accelerator system quality assurance device
Accessory to the 1230 3D SCANNER.
SUN NUCLEAR CORP.
12300004Z
Not in Commercial Distribution

  • B01612300004Z0 ()
12300004Z

  • Accelerator system quality assurance device
Overall size 24”W x 26.5”D x 74.5”T. 15.95 Cubic ft. storage Upper Chamber I.D. 20”W x 23”D x 15.25”T 4.05 Cubic ft. storage Temperature Range: 90-160 F Accuracy +/- 1 degrees F of set point Lower Chamber I.D. 20”W x 23”D x 34.5”T 11.9 Cubic ft. storage Temperature Range: 90-160 F Accuracy +/- 3 degrees F of set point 3 Adjustable shelves Digital control Upper Chamber glass door Lower Chamber steel door Audible and visual over-temp alarm Data Logger Keyed temperature lock Celcius Locking upper chamber door Foot levelers 4" base Electrical: 120V, 7.5 Amp, 50/60 Hz .46 kw/hr, 1570 btu/hr UL/CUL listed FDA Registered Electrical: 120V, 7.5 Amp, 50/60 Hz .46 kw/hr, 1570 btu/hr UL/CUL listed FDA Registered
FUTURE HEALTH CONCEPTS, INC.
FHCDWC2424-TL-G-D-CUST
In Commercial Distribution

  • B337FHCDWC2424TLGDCUST1 ()
FHCDWC2424-TL-G-D-CUST

  • Blanket warming cabinet, dry-heat
The Brain Sentinel® Seizure Detection and Warning System is an ambulatory system designed to monitor and analyze electromyography (EMG) data to detect the onset of a generalized tonic-clonic (GTC) seizure whether primary or focal onset with secondary generalization and to provide a warning signal to alert caregivers that a seizure is occurring. The system records EMG data (24/7) and is available for analysis of other motor events. The Brain Sentinel Seizure Detection and Warning System is intended for monitoring adults with a history or significant risk of generalized tonic-clonic seizures in the home or healthcare facilities, during the titration or withdrawal of anti-epileptic drugs, and for continuous monitoring, night time or any other time of day, of individuals due to their history or risk of generalized tonic-clonic seizures and will withstand activities of daily living including showers and sleep. The Brain Sentinel Seizure Detection and Warning System is available by prescription only.
BRAIN SENTINEL, INC.
SPC15
In Commercial Distribution

  • B481SPC15900451 ()
SPC15-90045

  • Home seizure monitoring system
The Brain Sentinel® Seizure Detection and Warning System is an ambulatory system designed to monitor and analyze electromyography (EMG) data to detect the onset of a generalized tonic-clonic (GTC) seizure whether primary or focal onset with secondary generalization and to provide a warning signal to alert caregivers that a seizure is occurring. The system records EMG data (24/7) and is available for analysis of other motor events. The Brain Sentinel Seizure Detection and Warning System is intended for monitoring adults with a history or significant risk of generalized tonic-clonic seizures in the home or healthcare facilities, during the titration or withdrawal of anti-epileptic drugs, and for continuous monitoring, night time or any other time of day, of individuals due to their history or risk of generalized tonic-clonic seizures and will withstand activities of daily living including showers and sleep. The Brain Sentinel Seizure Detection and Warning System is available by prescription only.
BRAIN SENTINEL, INC.
SPC15
In Commercial Distribution

  • B481SPC15900450 ()
SPC15-90045

  • Home seizure monitoring system
The Brain Sentinel® Seizure Detection and Warning System is an ambulatory system designed to monitor and analyze electromyography (EMG) data to detect the onset of a generalized tonic-clonic (GTC) seizure whether primary or focal onset with secondary generalization and to provide a warning signal to alert caregivers that a seizure is occurring. The system records EMG data (24/7) and is available for analysis of other motor events. The Brain Sentinel Seizure Detection and Warning System is intended for monitoring adults with a history or significant risk of generalized tonic-clonic seizures in the home or healthcare facilities, during the titration or withdrawal of anti-epileptic drugs, and for continuous monitoring, night time or any other time of day, of individuals due to their history or risk of generalized tonic-clonic seizures and will withstand activities of daily living including showers and sleep. The Brain Sentinel Seizure Detection and Warning System is available by prescription only.
BRAIN SENTINEL, INC.
SPC15
In Commercial Distribution

  • B481SPC15900441 ()
SPC15-90044

  • Home seizure monitoring system
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