FDA.reportPublic FDA data

CosyTherm

Primary DI
05060195340997
Brand
CosyTherm
Company
INSPIRATION HEALTHCARE GROUP PLC
Model
SHC101
Device description
SHC101 Control Unit
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
05060195340997PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060195340997050601953409975060195340997

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

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