FDA.reportPublic FDA data

AMMA

Primary DI
00850051245116
Brand
AMMA
Company
Cooler Heads Care, Inc.
Model
Accessory Kit, DTC, Small
Catalog number
831160
Published
2024-05-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
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
00850051245116PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850051245116008500512451168500512451160850051245116

GMDN Terms#

Term, Definition table
TermDefinition
Scalp cooling system, hair lossAn assembly of electrically-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.

Contacts#

Phone, Email table
PhoneEmail
1-619-930-9197info@coolerheads.com

Regulatory Flags#

DUNS number
116482614
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850051245239AMMAAccessory Kit, Large, 4-Pack530100-L2026-01-20
00850051245246AMMAAccessory Kit, Medium, 4-Pack530100-M2026-01-20
00850051245253AMMAAccessory Kit, Small, 4-Pack530100-S2026-01-20
00850051245192AMMAAccessory 4-Pack, Mixed8312502025-12-22
00850051245123AMMAAccessory Kit, DTC, Medium8311852024-05-03
00850051245130AMMAAccessory Kit, DTC, Large8311862024-05-03
00850051245000AMMAPSCS8307712023-10-24
00850051245017AMMAAccessory Kit, Small, 1-pack8310582023-10-24
00850051245024AMMAAccessory Kit, Medium, 1-pack8310572023-10-24
00850051245031AMMAAccessory Kit, Large, 1-pack8310562023-10-24
00850051245048AMMAStarter Kit8310402023-10-24

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
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
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