FDA.reportPublic FDA data

Surface Warming & Cooling System

Primary DI
10615089310208
Brand
Surface Warming & Cooling System
Company
ADROIT MEDICAL SYSTEMS, INC.
Model
A3
Catalog number
3102-0001
Device description
Surface Warming & Cooling System
Published
2020-10-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
ILOPack, Hot Or Cold, Water Circulating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILOPack, Hot Or Cold, Water CirculatingPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10615089310208PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1061508931020810615089310208

GMDN Terms#

Term, Definition table
TermDefinition
Circulating-fluid whole-body heating/cooling system control unitA mains electricity (AC-powered) device intended to be used as part of a circulating-fluid whole-body heating/cooling system to control/regulate the temperature and flow of fluid through a connected patient-applied pad (not included), for heating and alternatively cooling a patient’s whole-body (i.e., elevate or lower core body temperature). The device includes a heater and refrigeration unit, a pump, and typically a water reservoir; it may also be intended for patient temperature monitoring and typically includes alarms for cases of water temperatures beyond pre-set limits. It is intended to be used by a healthcare professional in a clinical setting (e.g., to achieve normothermia).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
865-458-8600scott@adroitmedical.com
8654588600kelley@adroitmedical.com

Regulatory Flags#

DUNS number
795104769
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
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
00749756401678DeRoyalDEROYAL INDUSTRIES, INC.ILO2026-09-18
06977782490029QuasarMDNingbo Jinhui Photoelectricity Technology Co., LtdILO2026-08-22
06977782490036QuasarMDNingbo Jinhui Photoelectricity Technology Co., LtdILO2026-08-22
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00812120005113Game Ready* Ankle Wrap, LargeAvanos Medical, Inc.ILO2026-07-31
00812120005120Game Ready* Ankle Wrap, Extra LargeAvanos Medical, Inc.ILO2026-07-31
00812120005137Game Ready* Shoulder Wrap, Medium, RightAvanos Medical, Inc.ILO2026-07-31
00812120005144Game Ready* Shoulder Wrap, Medium, LeftAvanos Medical, Inc.ILO2026-07-31
00812120005151Game Ready* Shoulder Wrap, Large, RightAvanos Medical, Inc.ILO2026-07-31
00812120005168Game Ready* Shoulder Wrap, Large, LeftAvanos Medical, Inc.ILO2026-07-31
00812120005175Game Ready* Back WrapAvanos Medical, Inc.ILO2026-07-31
00812120005182Game Ready* C-T Spine Wrap, LargeAvanos Medical, Inc.ILO2026-07-31
00812120005199Game Ready* Hip/Groin Wrap, RightAvanos Medical, Inc.ILO2026-07-31
00812120005205Game Ready* Hip/Groin Wrap, LeftAvanos Medical, Inc.ILO2026-07-31
00812120005212Game Ready* Hand/Wrist WrapAvanos Medical, Inc.ILO2026-07-31
00812120005229Game Ready* Flexed Elbow WrapAvanos Medical, Inc.ILO2026-07-31
00812120005236Game Ready* Half Leg Boot WrapAvanos Medical, Inc.ILO2026-07-31
00812120005243Game Ready* Full Leg Boot Wrap, LargeAvanos Medical, Inc.ILO2026-07-31
00812120005250Game Ready* Straight Knee SleeveAvanos Medical, Inc.ILO2026-07-31
00812120005267Game Ready* Articulated Knee SleeveAvanos Medical, Inc.ILO2026-07-31
00812120005274Game Ready* Straight Elbow SleeveAvanos Medical, Inc.ILO2026-07-31
00812120005281Game Ready* Ankle Sleeve, LargeAvanos Medical, Inc.ILO2026-07-31
00812120005298Game Ready* Ankle Sleeve, Extra LargeAvanos Medical, Inc.ILO2026-07-31
00812120005304Game Ready* Shoulder Sleeve, Medium, RightAvanos Medical, Inc.ILO2026-07-31
00812120005311Game Ready* Shoulder Sleeve, Medium, LeftAvanos Medical, Inc.ILO2026-07-31
00812120005328Game Ready* Shoulder Sleeve, Large, RightAvanos Medical, Inc.ILO2026-07-31
00812120005335Game Ready* Shoulder Sleeve, Large, LeftAvanos Medical, Inc.ILO2026-07-31
00812120005342Game Ready* Back SleeveAvanos Medical, Inc.ILO2026-07-31
00812120005359Game Ready* C-T Spine Sleeve, LargeAvanos Medical, Inc.ILO2026-07-31