FDA.reportPublic FDA data

ASTOPAD®

Primary DI
04260114140252
Brand
ASTOPAD®
Company
Stihler Electronic GmbH
Model
COV155-NA
Catalog number
COV155-NA
Device description
COV155-NA
Published
2020-10-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
DWJSystem, thermal regulating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWJSystem, Thermal RegulatingCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202197000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202197000Astopad Patient Warming SystemStihler Electronic GmbH2020-09-04DWJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260114140252PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260114140252042601141402524260114140252

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

Regulatory Flags#

DUNS number
317742377
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260114141488ThermAffyx™364903642026-09-21
04260114141532ThermAffyx™365903652026-09-21
04260114140221ASTOPAD®COV070-NACOV070-NA2020-10-08
04260114140238ASTOPAD®COV105-NACOV105-NA2020-10-08
04260114140245ASTOPAD®COV150-NACOV150-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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
0078755104171240675 Hot Pink Pad XL - with Arm ProtectorsXODUS MEDICAL, INC.DWJ2026-10-19
06951013004124KoZee Warming BlanketJiangmen Dacheng Medical Equipment Co., Ltd.DWJ2026-10-15
06950456323090NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323106NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323113NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323120NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323137NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323144NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323151NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323168NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323175NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323182NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323199NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323205NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323212NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323229NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323236NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323243NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323250NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323267NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323274NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323281NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323298NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323304NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323311NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323328NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323335NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323342NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323359NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323366NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30