FDA.reportPublic FDA data

Heating pad

Primary DI
06970285516906
Brand
Heating pad
Company
Shanghai CareUs Medical Product Co., Ltd.
Model
A1698
Published
2024-02-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

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
06970285516906PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970285516906069702855169066970285516906

GMDN Terms#

Term, Definition table
TermDefinition
External electric-heating core temperature regulation system padAn electrically-heated underlay or overlay intended to provide heat under or over a patient as part of an external electric-heating core temperature regulation system intended to elevate a patient’s core body temperature, typically in surgical and intensive care settings. The underlay/overlay typically contains electrical heating elements or cables supplied with energy by a dedicated control unit. The underlay/overlay is available in a variety of lengths, widths, and thicknesses to accommodate body size and application (e.g., adult/paediatric, full-/partial-body). This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
545814922
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970285517880CARE-US First Aid Bandages 40CT4097952026-03-27
06970285517897CARE-US First Aid Bandages 40CT4097952026-03-27
06970285517903CARE-US First Aid Bandages 40CT4097952026-03-27
06970285517910CARE-US First Aid Bandages 40CT4097952026-03-27
06970285517293Instant+ reusable gel packMedium2024-09-19
06970285515916REXALL KIDS GEL BEAD COMPRESS 1CT344583012022-07-27
06970285517347Careus3548972025-07-28
06970285517514Careus4097952025-07-10
06970285517521Careus4097952025-07-10
06970285517538Careus4097952025-07-10
06970285517545Careus4097952025-07-10
06970285517552Careus4097952025-07-10
06970285517569Careus4097952025-07-10
06970285517576Careus4097952025-07-10
06970285516586Careus4097952025-07-08
06970285517149Careus4097952025-07-08
06970285517255Careus4097952025-07-08
06970285517385Careus4098202025-06-18
06970285517408Careus4098222025-06-18
06970285517286Weekly pill planner7 Compartments2024-09-19

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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