FDA.reportPublic FDA data

Soft Air

Primary DI
10615089181105
Brand
Soft Air
Company
ADROIT MEDICAL SYSTEMS, INC.
Model
A400R
Catalog number
1811-0001
Device description
Blanket, Full Underbody, Reflective
Published
2017-03-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
K073712000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K073712000SOFT AIR, MODEL SA 4000 AND MISTRAL AIR, MODEL MA0100Adroit Medical Systems, Inc.2008-06-06DWJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20615089181102PackageGS110In Commercial Distribution
10615089181105PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2061508918110220615089181102
1061508918110510615089181105

GMDN Terms#

Term, Definition table
TermDefinition
Circulating-air whole-body heating system control unitA mains electricity (AC-powered) device intended to be used as part of a circulating-air whole-body heating system to filter, and control/regulate the temperature and flow of room air through a connected patient-applied pad (not included), for heating a patient’s whole-body (i.e., elevate core body temperature to achieve normothermia). The device includes a filter, an air heater and air pump. It is intended to be used by a healthcare professional in a clinical setting.

Contacts#

Phone, Email table
PhoneEmail
8654588600kelley@adroitmedical.com

Regulatory Flags#

DUNS number
795104769
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10615089100304Soft-TempST-003ST-0032016-09-23
10615089100809Soft-TempST-008ST-0082016-09-23
10615089101004Soft-TempST-010ST-0102016-09-23
10615089101400Soft-TempST-014ST-0142016-09-23
10615089101707Soft-TempST-017ST-0172016-09-23
10615089101905Soft-TempST-019ST-0192016-09-23
10615089102407Soft-TempST-024ST-0242016-09-23
10615089103008Soft-TempST-030ST-0302016-09-23
10615089104104Soft-TempST-041ST-0412016-09-23
10615089104302Soft-TempST-043ST-0432016-09-23
10615089104401Soft-TempST-044ST-0442016-09-23
10615089105002Soft-TempST-050ST-0502016-09-23
10615089111706Soft-TempWD-017WD-0172016-09-23
10615089112000Soft-TempWD-020WD-0202016-09-23
10615089113007Soft-TempWD-030WD-0302016-09-23
10615089116008Soft-TempWD-060WD-0602016-09-23
10615089121200Soft-TempST-212ST-2122016-09-23
10615089121705Soft-TempST-217ST-2172016-09-23
10615089122009Soft-TempST-220ST-2202016-09-23
10615089122405Soft-TempST-224ST-2242016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09332017002991CocoonCARE ESSENTIALS PTY LTDDWJ2026-04-29
09332017004131CocoonCARE ESSENTIALS PTY LTDDWJ2026-02-25
09332017004155CocoonCARE ESSENTIALS PTY LTDDWJ2026-02-25
10197344129072MEDLINEMEDLINE INDUSTRIES, INC.DWJ2025-05-07
10197344129089MEDLINEMEDLINE INDUSTRIES, INC.DWJ2025-05-07
08719867002639Mistral-AirThe Surgical Company International B.V.DWJ2025-01-30
08719867002653Mistral-AirThe Surgical Company International B.V.DWJ2025-01-30
09332017002861CocoonCARE ESSENTIALS PTY LTDDWJ2024-12-20
09332017003257CocoonCARE ESSENTIALS PTY LTDDWJ2024-09-13
09332017003295CocoonCARE ESSENTIALS PTY LTDDWJ2024-09-13
09332017003301CocoonCARE ESSENTIALS PTY LTDDWJ2024-09-13
09332017003318CocoonCARE ESSENTIALS PTY LTDDWJ2024-09-13
09332017003325CocoonCARE ESSENTIALS PTY LTDDWJ2024-09-13
09332017003332CocoonCARE ESSENTIALS PTY LTDDWJ2024-09-13
09332017003349CocoonCARE ESSENTIALS PTY LTDDWJ2024-09-13
08719867002646Mistral-Air®The Surgical Company International B.V.DWJ2024-07-08
08719867002660Mistral-Air®The Surgical Company International B.V.DWJ2024-07-08
10193489134773MEDLINEMEDLINE INDUSTRIES, INC.DWJ2024-06-25
10193489134780MEDLINEMEDLINE INDUSTRIES, INC.DWJ2024-06-25
10193489134797MEDLINEMEDLINE INDUSTRIES, INC.DWJ2024-06-25
10197344012770MEDLINEMEDLINE INDUSTRIES, INC.DWJ2024-06-25
10197344012817MEDLINEMEDLINE INDUSTRIES, INC.DWJ2024-06-25
10197344012831MEDLINEMEDLINE INDUSTRIES, INC.DWJ2024-06-25
10197344013401MEDLINEMEDLINE INDUSTRIES, INC.DWJ2024-06-25
10197344012794MedlineMEDLINE INDUSTRIES, INC.DWJ2024-04-30
09332017002885CocoonCARE ESSENTIALS PTY LTDDWJ2023-01-20
09332017002892CocoonCARE ESSENTIALS PTY LTDDWJ2023-01-20
09332017000645CocoonCARE ESSENTIALS PTY LTDDWJ2021-08-04
09332017002168CocoonCARE ESSENTIALS PTY LTDDWJ2021-08-04
09332017001178CocoonCARE ESSENTIALS PTY LTDDWJ2021-06-01