FDA.reportPublic FDA data

Game Ready* Wrap Extender Strap Kit, Rental

Primary DI
00812120005106
Brand
Game Ready* Wrap Extender Strap Kit, Rental
Company
Avanos Medical, Inc.
Model
120004998
Catalog number
573226-RN
Published
2026-04-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ILOPack, hot or cold, water circulating
IRPMassager, powered inflatable tube

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILOPack, Hot Or Cold, Water CirculatingPhysical Medicine2
IRPMassager, Powered Inflatable TubePhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812120005106PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812120005106008121200051068121200051060812120005106

GMDN Terms#

Term, Definition table
TermDefinition
Circulating-fluid localized thermal/compression therapy system wrapA non-sterile component of a circulating-fluid localized thermal/compression therapy system intended to facilitate, through thermal therapy (heating and/or cooling) and compression, the treatment of a variety of adverse conditions resulting from a musculoskeletal injury/orthopaedic surgery (e.g., pain, swelling, inflammation). It is intended to be fastened around a single or multiple anatomies and consists of: a heat exchanger, which enables heated and/or cooled fluid from the system control unit to be circulated; and an external sleeve, which enables intermittent compression via inflation. It is intended for use in both professional and home settings. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
+1(844)426-3732PIQ@AVANOS.COM

Regulatory Flags#

DUNS number
079375431
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00350770009148NeoMed120008812PNM-S35NC2026-07-21
00350770456096CLOG ZAPPER* with Applicator12000154520-00022019-06-21
10680651458350Halyard4583525-0082017-09-18
10680651458367Halyard4583625-0102017-09-18
10680651458374Halyard4583725-0122017-09-18
10680651469035Halyard4690325-0142017-09-18
10680651469042Halyard4690425-0162017-09-18
10680651469059Halyard4690525-0182017-09-18
00193494135263AVANOS*500108750010872020-09-25
10680651124767COOLIEF* Cooled Radiofrequency QUICKCLAMP* Device12476SIA-QC2016-05-17
00812120005083Game Ready* 6' Dual Connector Hose, Rental120004997570302-RN2026-04-24
00812120005090Game Ready* 6' Medical Connector Hose, Rental120004999570304-RN2026-04-24
00609038351117AVANOS35111351112020-04-01
00609038351124AVANOS35112351122020-04-01
00609038351131AVANOS35113351132020-04-01
00609038351148AVANOS35114351142020-04-01
00609038351155AVANOS35115351152020-04-01
00609038351162AVANOS35116351162020-04-01
00609038351179AVANOS35117351172020-04-01
00609038351186AVANOS35118351182020-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06953825911676N/AShenzhen Urion Technology Co., LtdIRP2026-07-24
00850087597081Recovery+ Go Compression UnitWMI ENTERPRISES, LLCIRP2026-07-23
06973641880444Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-07-21
06973641880444Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.IRP2026-07-21
06973641880512Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.IRP2026-07-21
06973641880512Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-07-21
06973641880680Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-07-21
06973641880680Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.IRP2026-07-21
06973641880765Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-07-21
06973641880765Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.IRP2026-07-21
06973641880772Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-07-21
06973641880772Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.IRP2026-07-21
06973641880789Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-07-21
06973641880789Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.IRP2026-07-21
06973641880796Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-07-21
06973641880796Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.IRP2026-07-21
06973641880802Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-07-21
06973641880802Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.IRP2026-07-21
06973641880819Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-07-21
06973641880819Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.IRP2026-07-21
06973641880826Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-07-21
06973641880826Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.IRP2026-07-21
06973641880871CryoRxChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-07-19
00840397513352Sharper ImageMerchsource, LLCIRP2026-06-28
08809040526691AIR RELAXMaxstar Industrial Co.,Ltd.IRP2026-04-27
08809040526707AIR RELAXMaxstar Industrial Co.,Ltd.IRP2026-04-27
08809040526714AIR RELAXMaxstar Industrial Co.,Ltd.IRP2026-04-27
08809040526721AIR RELAXMaxstar Industrial Co.,Ltd.IRP2026-04-27
00860015634924POWERPRESS UNITNEO MEDICIRP2026-03-31
06973641887146CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-03-12