FDA.reportPublic FDA data

ThermAffyx™

Primary DI
04260114141488
Brand
ThermAffyx™
Company
Stihler Electronic GmbH
Model
364
Catalog number
90364
Device description
ThermAffyx™ Controller Kit
Published
2026-09-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
DWJSystem, Thermal Regulating
LWGSurgical Table Cushion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWJSystem, Thermal RegulatingCardiovascular2
LWGSurgical Table CushionGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K260278000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K260278000ThermAffyx(TM) Patient Safety SystemStihler Electronic GmbH2026-07-08DWJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260114141495Direct MarkingGS10
04260114141488PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260114141495042601141414954260114141495
04260114141488042601141414884260114141488

GMDN Terms#

Term, Definition table
TermDefinition
Electric pad whole-body heating systemAn assembly of electrically-powered devices designed to heat a patient's whole body to compensate for the loss of normal body heat. The system includes a flat pad with electrical heating elements designed to be placed under or over the patient, and a control unit to regulate the heat; some types may be capable of monitoring the temperature at the patient’s body surface. The pad is available in a variety of lengths, widths, and thicknesses to accommodate body size and applications (e.g., adult/paediatric, full-/partial-body). It is typically used in the operating room (OR), adult or neonatal intensive care unit (ICU), recovery units, or during neonatal transportation.

Regulatory Flags#

DUNS number
317742377
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260114141532ThermAffyx™365903652026-09-21
04260114140221ASTOPAD®COV070-NACOV070-NA2020-10-08
04260114140238ASTOPAD®COV105-NACOV105-NA2020-10-08
04260114140245ASTOPAD®COV150-NACOV150-NA2020-10-08
04260114140252ASTOPAD®COV155-NACOV155-NA2020-10-08
04260114140269ASTOPAD®COV180-NACOV180-NA2020-10-08
04260114140030ASTOPAD®DUO310-NADUO310-NA2020-10-07
04260114141433ASTOTUBE®M77455502M774555022024-08-16
04260114141440ASTOTUBE®M774600022024-08-16
04260114141389ASTOTUBE®M77455502M774555022024-08-16
04260114141396ASTOTUBE®M774600022024-08-16
04260114140610ASTOTUBE®IFT40410IFT404102016-09-07
04260114140627ASTOTUBE®IFT30350IFT303502016-09-07
04260114140634ASTOTUBE®IFT30460IFT304602016-09-07
04260114140641ASTOTUBE®IFT30410IFT304102016-08-11
04260114140214ASTODIADIA1002023-07-18
04260114140375ASTOTHERM® PLUSAP220EUAP220EU2016-08-31
04260114140382ASTOTHERM® PLUSAP220SEUAP220SEU2016-08-31
04260114140399ASTOTHERM® PLUSAP260EUAP260EU2016-08-31
04260114140405ASTOTHERM® PLUSAP260SEUAP260SEU2016-08-31

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Primary DI, Brand, Company table
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06950456323373NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30