FDA.reportPublic FDA data

AIRCAST

Primary DI
00888912020374
Brand
AIRCAST
Company
Encore Medical, L.P.
Model
16A
Device description
HAND & WRIST CRYO/CUFF W/COOLR
Published
2016-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00888912020374PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888912020374008889120203748889120203740888912020374

GMDN Terms#

Term, Definition table
TermDefinition
Circulating-fluid thermal therapy system control unitA mains electricity (AC-powered) device intended to be used as part of a circulating-fluid thermal therapy system to pump heated and/or cooled fluid (e.g., water) through an externally applied pack (not included) for localized hot and/or cold therapy for the skin and/or underlying tissues (e.g., muscle) in the treatment of musculoskeletal pain and discomfort. It includes a fluid pump and either a heater, or a means for cold therapy (e.g., refrigeration unit, permitting addition of independently cooled ice water) or both; it does not include an air pump for wrap inflation. It is intended for use in both professional and home settings.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
154074504
Device count
1
Premarket exempt
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190446153818DJO SURGICAL495-00-0652017-02-28
00190446153825DJO SURGICAL495-00-0752017-02-28
00190446153832DJO SURGICAL495-00-0852017-02-28
00190446153849DJO SURGICAL495-01-0652017-02-28
00190446153856DJO SURGICAL495-01-0752017-02-28
00190446153863DJO SURGICAL495-01-0852017-02-28
00190446153917DJO SURGICAL495-14-1302017-03-30
00190446153924DJO SURGICAL495-14-1702017-03-07
00190446153931DJO SURGICAL495-14-2102017-03-07
00190446153948DJO SURGICAL495-15-1302017-03-07
00190446153955DJO SURGICAL495-15-1702017-03-07
00190446153962DJO SURGICAL495-15-2102017-03-07
00190446153979DJO SURGICAL495-16-1302017-03-03
00190446153986DJO SURGICAL495-16-1702017-03-03
00190446153993DJO SURGICAL495-16-2102017-03-03
00190446154006DJO SURGICAL495-17-1302017-03-03
00190446154013DJO SURGICAL495-17-1702017-03-03
00190446154020DJO SURGICAL495-17-2102017-03-03
00190446154037DJO SURGICAL495-18-1302017-03-03
00190446154044DJO SURGICAL495-18-1702017-03-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03858894530502ZT Cube - ZC3ZAMAR MEDICAL d.o.o.ILO2026-10-12
03858894530618ZT CLINICZAMAR MEDICAL d.o.o.ILO2026-10-12
00749756401678DeRoyalDEROYAL INDUSTRIES, INC.ILO2026-09-18
06977782490029QuasarMDNingbo Jinhui Photoelectricity Technology Co., LtdILO2026-08-22
06977782490036QuasarMDNingbo Jinhui Photoelectricity Technology Co., LtdILO2026-08-22
00812120004895Game Ready* SystemAvanos Medical, Inc.ILO2026-07-31
00812120005076Game Ready* Full Leg Boot Wrap, MediumAvanos Medical, Inc.ILO2026-07-31
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