FDA.reportPublic FDA data

SpeedHeat

Primary DI
05060195340492
Brand
SpeedHeat
Company
INSPIRATION HEALTHCARE GROUP PLC
Model
SHP013
Device description
SHP013 Pad
Published
2016-11-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true

Contact Domains#

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
05060195340492PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060195340492050601953404925060195340492

GMDN Terms#

Term, Definition table
TermDefinition
Electric pad whole-body heating systemAn assembly of mains electricity (AC-powered) devices designed to heat a patient's whole body, to compensate for the loss of normal body heat, with heat generated from an externally applied pad typically containing electrical heating elements or cables. The system includes the pad designed to heat under or over the patient, and a control unit to regulate and monitor the heat. The pads are available in a variety of lengths, widths, and thicknesses to accommodate body size and applications (e.g., adult/paediatric, full-/partial-body). The system is typically used in the operating room (OR), the intensive care unit (ICU), or in neonatal and recovery units.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+441709361000info@inspiration-healthcare.co
+441709361000info@inspiration-healthcare.com

Regulatory Flags#

DUNS number
235903494
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060195340003AlphaMECU12016-10-24
05060195340010AlphaOTM12016-10-24
05060195340027AlphaOTM22016-10-27
05060195340034AlphaGTM12016-10-27
05060195340041AlphaOTM1N2016-10-27
05060195340058AlphaOTM2N2016-10-27
05060195340065AlphaGTM1N2016-10-27
05060195340072AlphaOTB12016-10-27
05060195340089AlphaOTB22016-10-27
05060195340096AlphaRB12016-10-27
05060195340102AlphaRB22016-10-27
05060195340126CosythermCCU12016-10-27
05060195340140CosythermNCM12016-10-27
05060195340157CosythermNCM22016-10-27
05060195340164CosythermNCB12016-10-27
05060195340171CosythermPTM12016-10-27
05060195340218CosyCribCosyCrib Hood2016-11-03
05060195340225AlphaOTM-SPE2016-11-03
05060195340232AlphaRB-SPE2016-11-03
05060195340249AlphaOTB-SPE2016-11-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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