FDA.reportPublic FDA data

Tecotherm

Primary DI
05060206921498
Brand
Tecotherm
Company
INSPIRATION HEALTHCARE LIMITED
Model
TC-MATT-NEO
Device description
TC-MATT-NEO Reusable Mattress for Tecotherm Neo
Published
2016-11-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FOHMATTRESS, WATER, TEMPERATURE REGULATED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FOHMattress, Water, Temperature RegulatedGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060206921498PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060206921498050602069214985060206921498

GMDN Terms#

Term, Definition table
TermDefinition
Electroencephalographic monitoring system, stationaryA mains electricity (AC-powered) device assembly designed to continuously measure the electrical signals produced by a patient's brain and display/record them as an electroencephalogram (EEG) to evaluate brain function. It may be capable of monitoring various other physiological paramenters such as electromyogram (EMG), respiration wave forms, blood pressure, ocular motility, and/or haemoglobin oxygen saturation (SpO2) and carbon dioxide (CO2) in relation to EEG. It includes a control unit, electrodes, and components (e.g., amplifier, cables, probes); it is a stationary device and commonly used at the patient's bedside, in an intensive care unit (ICU), or in a dedicated EEG monitoring room.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
734903532
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
05060206921221TecothermNEO2016-11-07
05060206921757TecothermTC-MATT-DISP2016-11-07
05060206921764TecothermTC-BY-HOSE2016-11-07
05060206921771TecothermTC-MATT-NEO2016-11-07
05060206921788TecothermTC-FFL2016-11-07
05060206921795TecothermTC-MCC-1M2016-11-07
05060206921801TecothermTC-MCC-2M2016-11-07
05060206921818TecothermTC-MRK2016-11-07
05060206921726TecothermTC-CDT2016-11-07
05060206921733TecothermTC-CRS-NEO2016-11-07
05060206921740TecothermTC-CRS2016-11-07
05060206920088InspireIHC6052016-11-04
05060206920101InspireIHC6062016-11-07
05060206920125InspireIHC6072016-11-07
05060206921511InspireIHC6042016-11-07
05060206921672InspireIHBBH0052016-11-07
05060206920095InspireIHC6052016-11-04
05060206920118InspireIHC6062016-11-07
05060206920132InspireIHC6072016-11-07
05060206920149InspireIHC6082016-11-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00849111076098STX SURFACE COOLING Zoll Circulation, Inc.FOH2024-08-15
00849111076104STX SURFACE COOLING Zoll Circulation, Inc.FOH2024-08-15
00849111076111STX SURFACE COOLINGZoll Circulation, Inc.FOH2024-08-15
04260647540031TCmattTec Com Medizintechnik GmbHFOH2024-04-18
04260647540017TCmattTec Com Medizintechnik GmbHFOH2020-11-20
05060206921757TecothermINSPIRATION HEALTHCARE LIMITEDFOH2016-11-07
05060206921771TecothermINSPIRATION HEALTHCARE LIMITEDFOH2016-11-07