FDA.reportPublic FDA data

Tecotherm

Primary DI
05060206921757
Brand
Tecotherm
Company
INSPIRATION HEALTHCARE LIMITED
Model
TC-MATT-DISP
Device description
TC-MATT-DISP Disposable Aqua Wrap
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
Single use
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
05060206921757PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060206921757050602069217575060206921757

GMDN Terms#

Term, Definition table
TermDefinition
Circulating-fluid whole-body heating/cooling system pad, single-useA non-sterile underlay, overlay, or wrap(s) through which temperature-regulated fluid is circulated with the intention to heat and alternatively cool a patient’s whole-body (i.e., elevate or lower core body temperature) as part of a circulating-fluid whole-body heating/cooling system typically used in the operating room (OR), intensive care unit (ICU), or a recovery 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). It is intended to be used by a healthcare professional in a clinical setting. This is a single-use device.

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
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
05060206921498TecothermTC-MATT-NEO2016-11-07

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
05060206921498TecothermINSPIRATION HEALTHCARE LIMITEDFOH2016-11-07
05060206921771TecothermINSPIRATION HEALTHCARE LIMITEDFOH2016-11-07