FDA.reportPublic FDA data

AIRCAST

Primary DI
00190446293354
Brand
AIRCAST
Company
DJO, LLC
Model
30ICE
Device description
VENAPRO + ICEMAN CLASSIC CUBE
Published
2020-10-26
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
JOWSLEEVE, LIMB, COMPRESSIBLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILOPack, Hot Or Cold, Water CirculatingPhysical Medicine2
JOWSleeve, Limb, CompressibleCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190446293354PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190446293354001904462933541904462933540190446293354

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
081840873
Device count
1
Combination product
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190446979128AIRCAST31M-9002026-08-03
00190446898610CMFMFUSE012026-07-31
00190446660590PROCARE155-79-871132026-07-31
00190446660606PROCARE155-79-871142026-07-31
00190446660613PROCARE155-79-871172026-07-31
00190446660620PROCARE155-79-871182026-07-31
00190446660637PROCARE155-79-870502026-07-31
00190446660644PROCARE155-79-870602026-07-31
00190446922490CMFMANAGEL012026-07-31
00190446780601CHATTANOOGA81-50102023-04-25
00190446780618CHATTANOOGA81-50112023-04-25
00190446750598CHATTANOOGA47382022-09-02
00190446750604CHATTANOOGA47822022-09-02
00190446757214CHATTANOOGA4782-12022-09-02
00190446757221CHATTANOOGA4738-12022-09-02
00888912036627PROCARE79-892002022-08-22
00888912292856CHATTANOOGA2761-102016-09-15
00888912292863CHATTANOOGA2761-22016-09-15
00888912294249CHATTANOOGA2789-102016-09-15
00888912294256CHATTANOOGA2789-22016-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00636257188422MEDIMEDI MANUFACTURING, INC.JOW2026-10-27
00636257221785MEDIMEDI MANUFACTURING, INC.JOW2026-10-27
00636257221792MEDIMEDI MANUFACTURING, INC.JOW2026-10-27
00850078826213BioTAB LLCBiotab LLCJOW2026-10-26
00850078826220BioTAB LLCBiotab LLCJOW2026-10-26
00850078826237BioTAB LLCBiotab LLCJOW2026-10-26
00850078826244BioTAB LLCBiotab LLCJOW2026-10-26
00850078826251BioTAB LLCBiotab LLCJOW2026-10-26
00850078826268BioTAB LLCBiotab LLCJOW2026-10-26
00850078826275BioTAB LLCBiotab LLCJOW2026-10-26
00850078826282BioTAB LLCBiotab LLCJOW2026-10-26
00850078826299BioTAB LLCBiotab LLCJOW2026-10-26
00850078826305BioTAB LLCBiotab LLCJOW2026-10-26
00850078826312BioTAB LLCBiotab LLCJOW2026-10-26
00850078826329BioTAB LLCBiotab LLCJOW2026-10-26
03858894530502ZT Cube - ZC3ZAMAR MEDICAL d.o.o.ILO2026-10-12
03858894530618ZT CLINICZAMAR MEDICAL d.o.o.ILO2026-10-12
00850031012769AIROSAIROS MEDICAL INCJOW2026-10-09
00812311022448Sequential CirculatorBio Compression Systems, IncJOW2026-09-29
00812311022486Sequential CirculatorBio Compression Systems, IncJOW2026-09-29
00749756401678DeRoyalDEROYAL INDUSTRIES, INC.ILO2026-09-18
06977782490029QuasarMDNingbo Jinhui Photoelectricity Technology Co., LtdILO2026-08-22
06977782490036QuasarMDNingbo Jinhui Photoelectricity Technology Co., LtdILO2026-08-22
00190446979128AIRCASTDJO, LLCJOW2026-08-03
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