FDA.reportPublic FDA data

Mistral-Air

Primary DI
18719867001363
Brand
Mistral-Air
Company
The Surgical Company International B.V.
Model
MA3400-PM
Device description
Mistral-Air® Premium Full Underbody - SYK
Published
2022-05-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

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
K101705000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101705000MISTRAL-AIR WARMING SYSTEMThe Surgical Company International B.V.2010-07-02DWJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18719867001370PackageGS140In Commercial Distribution
18719867001363PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1871986700137018719867001370
1871986700136318719867001363

GMDN Terms#

Term, Definition table
TermDefinition
External circulating-air core temperature regulation system pad, single-useAn underlay or overlay through which temperature-regulated air is circulated as part of an external circulating-air core temperature regulation system, intended to elevate and/or lower a patient’s core body temperature, typically in surgical and intensive care settings. Air temperature and flow are regulated by a separate control unit (not included). The device is available in a variety of lengths, widths, thicknesses, and shapes to accommodate body size and application (e.g., adult/paediatric, full-/partial-body). This is a single-use device.

Regulatory Flags#

DUNS number
409656493
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
18719867001561Fluido® CompactWarming Module6502002024-02-09
18719867001776Fluido® CompactStandard Set6720002024-02-09
18719867001806Fluido® CompactStandard Set with Drip Chamber6721002024-02-09
18719867002421Fluido® CompactControl Module650100-US2024-02-09
08719867002752Fluido® AirGuard System671500-US2025-09-12
18719867002247Fluido® AirGuard System671200-US2025-09-12
08719867002769Fluido® AirGuard System671500-US2025-09-12
08719867002790Fluido® AirGuard System651115-US2025-09-12
18719867001615Fluido® AirGuard System660200A2025-09-12
18719867001622Fluido® AirGuard System6603002025-09-12
18719867001646Fluido® AirGuard System6614002025-09-12
18719867001653Fluido® AirGuard System660500-B2025-09-12
18719867002254Fluido® AirGuard System671200-US2025-09-12
18719867000243Mistral-AirMA16102023-06-05
18719867000281Mistral-AirMA16202023-06-05
18719867000328Mistral-AirMA16302023-06-05
18719867000366Mistral-AirMA16402023-06-05
18719867000403Mistral-AirMA17102023-06-05
18719867000441Mistral-AirMA17202023-06-05
18719867000489Mistral-AirMA17302023-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06950456323090NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
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06950456323137NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
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06950456323168NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
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06950456323236NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
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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
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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
06950456323373NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323380NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30