FDA.reportPublic FDA data

PSCS Coolant

Primary DI
B561COOLANTBATCH1
Brand
PSCS Coolant
Company
PAXMAN COOLERS LIMITED
Model
Coolant Batch
Catalog number
N/A
Device description
A consumable component of the Paxman Scalp Cooling System (PSCS) used as the cooling solution that is circulated within the system.
Published
2022-03-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PMCScalp Cooling System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PMCScalp Cooling SystemGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163484000
K173032000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163484000Paxman Scalp CoolerPaxman Coolers Limited2017-04-17PMC
K173032000Paxman Scalp CoolerPaxman Coolers Limited2018-06-07PMC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B561COOLANTBATCH1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Scalp cooling systemAn assembly of mains electricity (AC-powered) devices intended to reduce scalp hair loss associated with intravenous chemotherapy treatment by cooling the scalp to cause vasoconstriction and reduction of chemotherapy drug uptake by the follicular cells. It consists of a control unit which pumps a cooling agent to a head-worn cap containing coolant channels and temperature monitoring sensors. An insulating cap (e.g., neoprene) may be worn over the cooling cap to secure it and prevent condensation.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
844-572-9626patient@paxmanusa.com

Regulatory Flags#

DUNS number
519917264
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B561PSCSKITL251Paxman cap kitLarge, 25 creditsPSCS-KIT-L252022-03-18
B561PSCSKITLA251Paxman cap kitLarge Asian, 25 creditsPSCS-KIT-LA252022-03-18
B561PSCSKITM251Paxman cap kitMedium, 25 creditsPSCS-KIT-M252022-03-18
B561PSCSKITMA251Paxman cap kitMedium Asian, 25 creditsPSCS-KIT-MA252022-03-18
B561PSCSKITMS251Paxman cap kitMedium/Small, 25 creditsPSCS-KIT-M/S252022-03-18
B561PSCSKITS251Paxman cap kitSmall, 25 creditsPSCS-KIT-S252022-03-18
B561PSCSKITSA251Paxman cap kitSmall Asian, 25 creditsPSCS-KIT-SA252022-03-18
B561CAPBATCH1Paxman Cooling capCap BatchN/A2022-03-07
B561CAPSIZINGPACKA1Paxman Cooling capSizing pack AsianPSCS-CAP-APACK2022-03-07
B561PSCSCAPMEDSML0Paxman Cooling CapMedium/SmallPSCS-CAP-M/S2022-03-07
B561PSCSCAPASIANLARGE0Paxman Cooling CapLarge AsianPSCS-CAP-LRGA2020-09-21
B561PSCSCAPASIANMEDIUM0Paxman Cooling CapMedium AsianPSCS-CAP-MEDA2020-09-21
B561PSCSCAPASIANSMALL0Paxman Cooling CapSmall AsianPSCS-CAP-SMLA2020-09-21
B5611LCOOLANT0PSCS Coolant1L300-16-012018-04-05
B5613LCOOLANT0PSCS Coolant3L300-16-022018-04-05
B561ACCESSORIES2Paxman AccessoriesAccessories PackAccessories Pack2018-04-05
B561CAPSIZINGPACK1Paxman Cooling capSizing packPSCS-CAP-PACK2018-04-05
B561COOLANTCOMMPACK1PSCS CoolantComm Pack300-16-032018-04-05
B561PSCS1115VPFU0PSCS1PSCS1 110V-PFU2018-03-29
B561PSCS2115VPFU0PSCS2PSCS2 110V-PFU2018-04-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
89080300020134Eva Scalp Cooling System STEMTECH MEDICAL DEVICES PRIVATE LIMITEDPMC2026-05-04
89080300020202Eva Scalp Cooling SystemSTEMTECH MEDICAL DEVICES PRIVATE LIMITEDPMC2026-05-04
89080300020370Eva Scalp Cooling SystemSTEMTECH MEDICAL DEVICES PRIVATE LIMITEDPMC2026-05-04
89080300020066Eva Scalp Cooling SystemSTEMTECH MEDICAL DEVICES PRIVATE LIMITEDPMC2026-05-01
00850051245239AMMACooler Heads Care, Inc.PMC2026-01-20
00850051245246AMMACooler Heads Care, Inc.PMC2026-01-20
00850051245253AMMACooler Heads Care, Inc.PMC2026-01-20
00850051245192AMMACooler Heads Care, Inc.PMC2025-12-22
00850051245116AMMACooler Heads Care, Inc.PMC2024-05-03
00850051245123AMMACooler Heads Care, Inc.PMC2024-05-03
00850051245130AMMACooler Heads Care, Inc.PMC2024-05-03
00850051245000AMMACooler Heads Care, Inc.PMC2023-10-24
00850051245017AMMACooler Heads Care, Inc.PMC2023-10-24
00850051245024AMMACooler Heads Care, Inc.PMC2023-10-24
00850051245031AMMACooler Heads Care, Inc.PMC2023-10-24
00850051245048AMMACooler Heads Care, Inc.PMC2023-10-24
00851682007562Cooler HeadsPATHWAY, LLCPMC2022-11-07
B561PSCSKITL251Paxman cap kitPAXMAN COOLERS LIMITEDPMC2022-03-18
B561PSCSKITLA251Paxman cap kitPAXMAN COOLERS LIMITEDPMC2022-03-18
B561PSCSKITM251Paxman cap kitPAXMAN COOLERS LIMITEDPMC2022-03-18
B561PSCSKITMA251Paxman cap kitPAXMAN COOLERS LIMITEDPMC2022-03-18
B561PSCSKITMS251Paxman cap kitPAXMAN COOLERS LIMITEDPMC2022-03-18
B561PSCSKITS251Paxman cap kitPAXMAN COOLERS LIMITEDPMC2022-03-18
B561PSCSKITSA251Paxman cap kitPAXMAN COOLERS LIMITEDPMC2022-03-18
B561CAPBATCH1Paxman Cooling capPAXMAN COOLERS LIMITEDPMC2022-03-07
B561CAPSIZINGPACKA1Paxman Cooling capPAXMAN COOLERS LIMITEDPMC2022-03-07
B561PSCSCAPMEDSML0Paxman Cooling CapPAXMAN COOLERS LIMITEDPMC2022-03-07
00850036106005DigniCap® DeltaDignitana ABPMC2022-02-02
00850036106036DigniCap® DeltaDignitana ABPMC2022-02-02
00850036106074DigniCap® DeltaDignitana ABPMC2022-02-02