FDA.reportPublic FDA data

Tecotherm

Primary DI
05060206921818
Brand
Tecotherm
Company
INSPIRATION HEALTHCARE LIMITED
Model
TC-MRK
Device description
TC-MRK Mattress Repair Kit
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
KGXTape and bandage, adhesive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060206921818PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060206921818050602069218185060206921818

GMDN Terms#

Term, Definition table
TermDefinition
Circulating-fluid whole-body heating/cooling system pad, reusableAn 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). It is intended to be used by a healthcare professional in a clinical setting. This is a reusable 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
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
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
069740214114323H MedicalWAL-MART STORES, INC.KGX2026-07-31
069740214114943H MedicalWAL-MART STORES, INC.KGX2026-07-31
06979191882112NanacareWAL-MART STORES, INC.KGX2026-07-31
06979191882228NanacareWAL-MART STORES, INC.KGX2026-07-31
06979191882242NanacareWAL-MART STORES, INC.KGX2026-07-31
06979191882273BadBuddyWAL-MART STORES, INC.KGX2026-07-31
06979191883591OKTAPEHTT Technologies, Inc.KGX2026-07-31
06979191883607OKTAPEHTT Technologies, Inc.KGX2026-07-31
06979191883690EQUATEWAL-MART STORES, INC.KGX2026-07-31
06979191883706EQUATEWAL-MART STORES, INC.KGX2026-07-31
06979191883713EQUATEWAL-MART STORES, INC.KGX2026-07-31
06979191883720EquateWAL-MART STORES, INC.KGX2026-07-31
06980297490019HuixiangJiangsu Huixiang Intelligent Technology Co., LtdKGX2026-07-31
20618125192339AquaGuardTIDI PRODUCTS, LLCKGX2026-07-28
20618125192384AquaGuardTIDI PRODUCTS, LLCKGX2026-07-28
20618125192391AquaGuardTIDI PRODUCTS, LLCKGX2026-07-28
00850086064003BRIJ-SEALBRIJ Medical, Inc.KGX2026-07-17
B14350202030IDcheck SensorBeacon Biosignals, Inc.KGX2026-07-17
00850088144598CARBOUNingbo kehu Medical Technology Co.,Ltd.KGX2026-07-10
00850088144093CARBOUNingbo kehu Medical Technology Co.,Ltd.KGX2026-07-01
14931921902902BLUPRO Attachment TapeNIHON KOHDEN CORPORATIONKGX2026-06-23
00850087488556CeeportCEEPORT INC.KGX2026-06-12
16973405130119AODEJIANWenzhou Anqi Medical Supplies Co., LtdKGX2026-06-10
00049696189583THERA PlusFOURSTAR GROUP INC.KGX2026-06-09
00049696561228THERA PlusFOURSTAR GROUP INC.KGX2026-06-09
00049696677547THERA PlusFOURSTAR GROUP INC.KGX2026-06-09
00197344129099CURADMEDLINE INDUSTRIES, INC.KGX2026-06-09
08809302586364Soosung Self-Adhesive Bandagesoosung medicalKGX2026-06-08
08809302586395Soosung Self-Adhesive Bandagesoosung medicalKGX2026-06-08
08809302586425Soosung Self-Adhesive Bandagesoosung medicalKGX2026-06-08