FDA.reportPublic FDA data

Mistral-Air

Primary DI
18719867001059
Brand
Mistral-Air
Company
The Surgical Company International B.V.
Model
MA2450-PM
Device description
Mistral-Air® Half Underbody Plus – SYK
Published
2022-05-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
18719867001059PackageGS140In Commercial Distribution
18719867001042PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1871986700105918719867001059
1871986700104218719867001042

GMDN Terms#

Term, Definition table
TermDefinition
Circulating-air whole-body heating/cooling system pad, single-use, non-sterileA non-sterile underlay or overlay through which heated or cooled air is circulated to heat and alternatively cool a patient’s whole-body (i.e., elevate or lower core body temperature) typically in surgical and intensive care settings. Air temperature and flow are regulated by a separate control unit. 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
409656493
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
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
06950456323373NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323380NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30