FDA.reportPublic FDA data

Cooler Heads

Primary DI
00851682007562
Brand
Cooler Heads
Company
PATHWAY, LLC
Model
830771
Device description
AMMA Portable Scalp Cooling System
Published
2022-11-07
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K211526000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211526000Portable Scalp Cooling SystemCooler Heads Care, Inc.2021-10-21PMC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851682007562PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851682007562008516820075628516820075620851682007562

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

Regulatory Flags#

DUNS number
080312381
Device count
1
DM exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860009140509UpLyftST-1202023-08-08
00851682007005Kurin Blood Collection Set, 21 Ga, BioMerieuxM-112212017-03-13
00851682007012Kurin Blood Collection Set, 23 Ga, BD BioMerieuxM-112232017-03-13
00851682007036Kurin Blood Collection Set, 21 Ga, BD VacutainerD-112212017-03-13
00851682007067Kurin Blood Collection Set, 23 Ga, Push Button Needle, BioMerieuxM-212232017-03-13
00851682007074Kurin Blood Collection Set, 23 Ga, Push Button Needle, BD VacutainerD-212232017-03-13
00851682007081Kurin Blood Collection Set, 21 Ga, Push Button Needle, BioMerieux ShieldM-212212017-03-13
00851682007104Kurin Blood Collection Set, 21 Ga, Push Button Needle, BD VacutainerD-212212017-03-13
20851682007009Kurin Blood Collection Set, 21 Ga, BioMerieuxM-112212017-03-13
20851682007016Kurin Blood Collection Set, 23 Ga, BD BioMerieuxM-112232017-03-13
20851682007030Kurin Blood Collection Set, 21 Ga, BD VacutainerD-112212017-03-13
20851682007061Kurin Blood Collection Set, 23 Ga, Push Button Needle, BioMerieuxM-212232017-03-13
20851682007078Kurin Blood Collection Set, 23 Ga, Push Button Needle, BD VacutainerD-212232017-03-13
00851682007043Kurin Blood Collection Set, 23 Ga, BD VacutainerD-112232017-03-13
20851682007047Kurin Blood Collection Set, 23 Ga, BD VacutainerD-112232017-03-13

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
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
B561COOLANTBATCH1PSCS CoolantPAXMAN 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