FDA.reportPublic FDA data

Pixie Cup

Primary DI
00850068130511
Brand
Pixie Cup
Company
Pixie Cup LLC
Model
Eva Thermal (Pink)
Device description
Eva Thermal (Pink)
Published
2025-05-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IRTPad, Heating, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IRTPad, Heating, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850068130511PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850068130511008500681305118500681305110850068130511

GMDN Terms#

Term, Definition table
TermDefinition
Electric pad localized-body heating systemAn assembly of mains electricity (AC-powered) devices designed for the transcutaneous application of heat to a localized body site (e.g., joint, limb) to relieve musculoskeletal pain. It consists of an electric heating pad typically made of synthetic fabric materials, and a hand-held control unit used to regulate and monitor the heat. It is intended for use in the home or a clinical setting.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
028513002
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850068130863Pixie CupB0GMXXDH8J2026-03-19
00850068130870Pixie CupB0GMT9C1KH2026-03-19
00850068130887Pixie CupB0GMVH5VXD2026-03-19
00850068130894Pixie CupB0GMTK2PST2026-03-19
00850068130900Pixie CupB0GMTQHF3Z2026-03-19
00850068130917Pixie CupB0GMSQ371C2026-03-19
00850068130924Pixie CupB0GMTGNF1M2026-03-19
00850068130931Pixie CupB0GMT62Y3Y2026-03-19
00850068130948Pixie CupB0GMSKKK1S2026-03-19
00715875074840Pixie CupM2506PC1915A2025-06-25
00869352000324Pixie CupB019632Z0E2023-09-28
00850016867407Pixie CupB0BFNLQC4L2026-01-09
00850016867209Pixie CupB09NQDYZMW2025-11-05
00850016867254Pixie CupB09Y8YP43N2023-09-28
00869352000317Pixie CupB0197T6IEQ2023-09-28
00850068130221Pixie CupB0FJBG2VVN2025-08-02
00850016867780Pixie CupM2506PD2023A2025-06-24
00860417001393Pixie CupM2506PD2020A2025-06-26
00869352000348Pixie Cup250708G0032025-06-26
00850016867742Pixie CupM2506PC1911A2025-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00041298995043DMID-M-S HOLDINGS, INC.IRT2025-12-30
09413000135374Flowpresso Compression DeviceMEDELLA HEALTH LIMITEDIRT2025-10-16
00041298991960DMID-M-S HOLDINGS, INC.IRT2025-06-12
00031262116291HomedicsHuizhou XINYI Technology Co., LTDIRT2025-02-01
00031262116697HomedicsHuizhou XINYI Technology Co., LTDIRT2025-01-01
00031262116666HomedicsHuizhou XINYI Technology Co., LTDIRT2024-12-31
00031262109507HomedicsHuizhou XINYI Technology Co., LTDIRT2024-11-12
00031262113306HomedicsFKA DISTRIBUTING CO., LLCIRT2024-09-30
00031262115416HomedicsFKA DISTRIBUTING CO., LLCIRT2024-09-30
00031262115379HomedicsFKA DISTRIBUTING CO., LLCIRT2024-08-30
00031262115386HomedicsFKA DISTRIBUTING CO., LLCIRT2024-08-30
00031262115393HomedicsFKA DISTRIBUTING CO., LLCIRT2024-08-30
00031262115423HomedicsFKA DISTRIBUTING CO., LLCIRT2024-08-30
00031262115768HomedicsFKA DISTRIBUTING CO., LLCIRT2024-08-30
00041298991953DMID-M-S HOLDINGS, INC.IRT2024-02-28
B311PETNHTPR0PURE ENRICHMENTBEAR DOWN CONSULTINGIRT2023-12-15
00031262110527HOMEDICSFKA DISTRIBUTING CO., LLCIRT2023-08-21
00031262108739HOMEDICSFKA DISTRIBUTING CO., LLCIRT2023-08-10
00031262110541HOMEDICSFKA DISTRIBUTING CO., LLCIRT2023-08-10
00031262110640HOMEDICSFKA DISTRIBUTING CO., LLCIRT2023-08-10
00041298051312DMID-M-S HOLDINGS, INC.IRT2023-06-06
00041298991489DMID-M-S HOLDINGS, INC.IRT2023-03-17
00041298051336DMID-M-S HOLDINGS, INC.IRT2023-03-14
00011822820240Rite AidRITE AID CORPORATIONIRT2022-10-20
00011822820226Rite AidRITE AID CORPORATIONIRT2022-05-31
00031262101730HOMEDICSHOMEDICS USA, LLCIRT2021-06-01
00031262101556HOMEDICSFKA DISTRIBUTING CO., LLCIRT2021-05-28
16971912180030Walgreens heating padNINGBO BELLA VIE CO., LTDIRT2021-05-11
16971912180016RENPHO heating padNINGBO BELLA VIE CO., LTDIRT2021-03-31
16971912180023Walgreens heating padNINGBO BELLA VIE CO., LTDIRT2021-03-31