paxmanusa.comPaxman Scalp Cooler
Paxman Coolers Limited
PAXMAN COOLERS LIMITED
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3008938259 | 3008938259 | PAXMAN COOLERS LIMITED | 1 | N | 2026-01-01 | International House Penistone Road Fenay Bridge, Huddersfield Kirklees GB HD8 0LE |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| B561CAPBATCH1 | Paxman Cooling cap - Multiple caps sent in a single box | 844-572-9626 | patient@paxmanusa.com |
| B561PSCSKITL251 | Paxman cap kit - 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. | 844-572-9626 | patient@paxmanusa.com |
| B561PSCSKITLA251 | Paxman cap kit - 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. | 844-572-9626 | patient@paxmanusa.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 208149 | 1526810700 | K173032 | Paxman Scalp Cooler | PMC | 2018-06-07 |
| 208149 | 1176075086 | K163484 | Paxman Scalp Cooler | PMC | 2017-04-17 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| PMC | 2 | 2018-06-07 |
PMN#
Paxman Scalp Cooler
Paxman Coolers Limited
GUDID#
Paxman cap kit - 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.
2022-03-18
Paxman cap kit - 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.
2022-03-18
Paxman cap kit - 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.
2022-03-18
Paxman cap kit - 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.
2022-03-18
Paxman cap kit - 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.
2022-03-18
Paxman cap kit - 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.
2022-03-18
Paxman cap kit - 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.
2022-03-18
Paxman Cooling cap - Multiple caps sent in a single box
2022-03-07
Paxman Cooling cap - All sizes of Paxman Cooling Cap provided to healthcare facilities in order to establish correct sizes for patients.
2022-03-07
PSCS Coolant - A consumable component of the Paxman Scalp Cooling System (PSCS) used as the cooling solution that is circulated within the system.
2022-03-07
Paxman Cooling Cap - Paxman Cooling Cap which consists of a silicone inner layer and neoprene outer cover that connects to the Paxman Scalp Cooling System (PSCS) to provide scalp cooling treatment.
2022-03-07
Paxman Cooling Cap - Paxman Cooling Cap which consists of a silicone inner layer and neoprene outer cover that connects to the Paxman Scalp Cooling System (PSCS) to provide scalp cooling treatment.
2020-09-21
Paxman Cooling Cap - Paxman Cooling Cap which consists of a silicone inner layer and neoprene outer cover that connects to the Paxman Scalp Cooling System (PSCS) to provide scalp cooling treatment.
2020-09-21
Paxman Cooling Cap - Paxman Cooling Cap which consists of a silicone inner layer and neoprene outer cover that connects to the Paxman Scalp Cooling System (PSCS) to provide scalp cooling treatment.
2020-09-21
PSCS Coolant - A consumable component of the Paxman Scalp Cooling System (PSCS) used as the cooling solution that is circulated within the system.
2018-04-05
PSCS Coolant - A consumable component of the Paxman Scalp Cooling System (PSCS) used as the cooling solution that is circulated within the system.
2018-04-05
Paxman Accessories - Accessory items used to support the use of the PSCS device.
2018-04-05
Paxman Cooling cap - All sizes of Paxman Cooling Cap provided to healthcare facilities in order to establish correct sizes for patients.
2018-04-05
PSCS Coolant - 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.
2018-04-05
PSCS - 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.
2018-03-29
PSCS - 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.
2018-04-04
Paxman Cooling Cap - Paxman Cooling Cap which consists of a silicone inner layer and neoprene outer cover that connects to the Paxman Scalp Cooling System (PSCS) to provide scalp cooling treatment.
2018-04-05
Paxman Cooling Cap - Paxman Cooling Cap which consists of a silicone inner layer and neoprene outer cover that connects to the Paxman Scalp Cooling System (PSCS) to provide scalp cooling treatment.
2018-04-05
Paxman Cooling Cap - Paxman Cooling Cap which consists of a silicone inner layer and neoprene outer cover that connects to the Paxman Scalp Cooling System (PSCS) to provide scalp cooling treatment.
2018-04-05