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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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The Paxman Scalp Cooling System (PSCS) is a compact, mobile refrigeration unit that has been tested to IEC 60601 safety standards for medical devices. The unit circulates a refrigerated liquid coolant, at low pressure, through a special cooling cap that is positioned on the patient’s head. The circulation of the refrigerated coolant through the cap extracts heat from the patient’s scalp and maintains it at the optimum temperature for scalp cooling. There are two versions of the device. One is for single patient use, PSCS1, the other is for two patient use, PSCS2.
PAXMAN COOLERS LIMITED
2
In Commercial Distribution

  • B561PSCS2115VPFU0 ()
PSCS2 110V-PFU

  • Scalp cooling system, hair loss
The Paxman Scalp Cooling System (PSCS) is a compact, mobile refrigeration unit that has been tested to IEC 60601 safety standards for medical devices. The unit circulates a refrigerated liquid coolant, at low pressure, through a special cooling cap that is positioned on the patient’s head. The circulation of the refrigerated coolant through the cap extracts heat from the patient’s scalp and maintains it at the optimum temperature for scalp cooling. There are two versions of the device. One is for single patient use, PSCS1, the other is for two patient use, PSCS2.
PAXMAN COOLERS LIMITED
1
In Commercial Distribution

  • B561PSCS1115VPFU0 ()
PSCS1 110V-PFU

  • Scalp cooling system, hair loss
A consumable component of the Paxman Scalp Cooling System (PSCS) used as the cooling solution that is circulated within the system. This pack of coolant is used for commissioning the system.
PAXMAN COOLERS LIMITED
Comm Pack
In Commercial Distribution

  • B561COOLANTCOMMPACK1 ()
300-16-03

  • Scalp cooling system, hair loss
A consumable component of the Paxman Scalp Cooling System (PSCS) used as the cooling solution that is circulated within the system.
PAXMAN COOLERS LIMITED
Coolant Batch
In Commercial Distribution

  • B561COOLANTBATCH1 ()
N/A

  • Scalp cooling system, hair loss
All sizes of Paxman Cooling Cap provided to healthcare facilities in order to establish correct sizes for patients.
PAXMAN COOLERS LIMITED
Sizing pack Asian
In Commercial Distribution

  • B561CAPSIZINGPACKA1 ()
PSCS-CAP-APACK

  • Scalp cooling system, hair loss
All sizes of Paxman Cooling Cap provided to healthcare facilities in order to establish correct sizes for patients.
PAXMAN COOLERS LIMITED
Sizing pack
In Commercial Distribution

  • B561CAPSIZINGPACK1 ()
PSCS-CAP-PACK

  • Scalp cooling system, hair loss
Multiple caps sent in a single box
PAXMAN COOLERS LIMITED
Cap Batch
In Commercial Distribution

  • B561CAPBATCH1 ()
N/A

  • Scalp cooling system, hair loss
Accessory items used to support the use of the PSCS device.
PAXMAN COOLERS LIMITED
Accessories Pack
Not in Commercial Distribution

  • B561ACCESSORIES2 ()
Accessories Pack

  • Scalp cooling system, hair loss
A consumable component of the Paxman Scalp Cooling System (PSCS) used as the cooling solution that is circulated within the system.
PAXMAN COOLERS LIMITED
3L
In Commercial Distribution

  • B5613LCOOLANT0 ()
300-16-02

  • Scalp cooling system, hair loss
A consumable component of the Paxman Scalp Cooling System (PSCS) used as the cooling solution that is circulated within the system.
PAXMAN COOLERS LIMITED
1L
In Commercial Distribution

  • B5611LCOOLANT0 ()
300-16-01

  • Scalp cooling system, hair loss
Paxman Cooling Cap Kit which consists of a Paxman Cooling Cap, haircare accessories and patient information on scalp cooling. The Paxman Cooling Cap consists of a silicone inner layer and neoprene outer cover that connects to the Paxman Scalp Cooling System (PSCS) to provide scalp cooling treatment.
PAXMAN COOLERS LIMITED
Small Asian, 25 credits
In Commercial Distribution

  • B561PSCSKITSA251 ()
PSCS-KIT-SA25

  • Scalp cooling system, hair loss
Paxman Cooling Cap Kit which consists of a Paxman Cooling Cap, haircare accessories and patient information on scalp cooling. The Paxman Cooling Cap consists of a silicone inner layer and neoprene outer cover that connects to the Paxman Scalp Cooling System (PSCS) to provide scalp cooling treatment.
PAXMAN COOLERS LIMITED
Small, 25 credits
In Commercial Distribution

  • B561PSCSKITS251 ()
PSCS-KIT-S25

  • Scalp cooling system, hair loss
Paxman Cooling Cap Kit which consists of a Paxman Cooling Cap, haircare accessories and patient information on scalp cooling. The Paxman Cooling Cap consists of a silicone inner layer and neoprene outer cover that connects to the Paxman Scalp Cooling System (PSCS) to provide scalp cooling treatment.
PAXMAN COOLERS LIMITED
Medium/Small, 25 credits
In Commercial Distribution

  • B561PSCSKITMS251 ()
PSCS-KIT-M/S25

  • Scalp cooling system, hair loss
Paxman Cooling Cap Kit which consists of a Paxman Cooling Cap, haircare accessories and patient information on scalp cooling. The Paxman Cooling Cap consists of a silicone inner layer and neoprene outer cover that connects to the Paxman Scalp Cooling System (PSCS) to provide scalp cooling treatment.
PAXMAN COOLERS LIMITED
Medium Asian, 25 credits
In Commercial Distribution

  • B561PSCSKITMA251 ()
PSCS-KIT-MA25

  • Scalp cooling system, hair loss
Paxman Cooling Cap Kit which consists of a Paxman Cooling Cap, haircare accessories and patient information on scalp cooling. The Paxman Cooling Cap consists of a silicone inner layer and neoprene outer cover that connects to the Paxman Scalp Cooling System (PSCS) to provide scalp cooling treatment.
PAXMAN COOLERS LIMITED
Medium, 25 credits
In Commercial Distribution

  • B561PSCSKITM251 ()
PSCS-KIT-M25

  • Scalp cooling system, hair loss
Paxman Cooling Cap Kit which consists of a Paxman Cooling Cap, haircare accessories and patient information on scalp cooling. The Paxman Cooling Cap consists of a silicone inner layer and neoprene outer cover that connects to the Paxman Scalp Cooling System (PSCS) to provide scalp cooling treatment.
PAXMAN COOLERS LIMITED
Large, 25 credits
In Commercial Distribution

  • B561PSCSKITL251 ()
PSCS-KIT-L25

  • Scalp cooling system, hair loss
Disposable Thermometer Probe/Drager/Pediatri/Skin/Injection molding straight groove with bump/1.5M
Unimed Medical Supplies, Inc.
TDGC15-DPS
In Commercial Distribution

  • 06945664858793 ()


  • General-purpose patient temperature probe, single-use
Reusable Thermometer Probe/YSI400/Adult/Skin/6.3 mono male/3.0M/Coast Biomedical Equipment
Unimed Medical Supplies, Inc.
C415-0023
In Commercial Distribution

  • 06945664855570 ()


  • General-purpose patient temperature probe, reusable
VeinViewer Flex is designed for ease of use. VeinViewer Flex utilizes visible and near-infrared light for vascular imaging to illuminate and project the subcutaneous venous structure directly onto a patient’s skin. AVIN™ (Active Vascular Imaging Navigation) allows the user to assess multiple access points with a re al-time digital image .
Christie Medical Holdings, Inc.
3.0 Flex
In Commercial Distribution

  • M870134002102021 ()
134-002102-02

  • Hand-held multi-spectral vascular imaging device
Vitals360 Multi-Vitals Mobile Monitor VC-001
Vocare, Inc.
VC-001
In Commercial Distribution

  • 10860007323406 ()
  • 00860007323409 ()
  • 20860007323403 ()
  • 30860007323400 ()


  • Pulse oximeter
  • Infrared patient thermometer, skin
  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
  • Multiple vital physiological parameter monitoring system, clinical
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