FDA.reportPublic FDA data

Game Ready

Primary DI
00812120001825
Brand
Game Ready
Company
Avanos Medical, Inc.
Model
510434-03
Device description
Left Shoulder Sleeve - Large
Published
2018-01-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K072620000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072620000GAME READY CLASSIC SYSTEM, MODEL 550550Coolsystems, Inc.2007-10-31IRP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812120001825PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812120001825008121200018258121200018250812120001825

GMDN Terms#

Term, Definition table
TermDefinition
Body-orifice ultrasound imaging transducer cover, basic, sterileA sterile sheath intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gliding creams) and/or to maintain the required hygienic level of an ultrasound imaging system transducer (probe) used in natural body orifices (e.g., vagina, rectum, oesophagus) during an ultrasound examination; it has no additional functionality. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079375431
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00812120005106Game Ready* Wrap Extender Strap Kit, Rental120004998573226-RN2026-04-17
00609038351117AVANOS35111351112020-04-01
00609038351124AVANOS35112351122020-04-01
00609038351131AVANOS35113351132020-04-01
00609038351148AVANOS35114351142020-04-01
00609038351155AVANOS35115351152020-04-01
00609038351162AVANOS35116351162020-04-01
00609038351179AVANOS35117351172020-04-01
00609038351186AVANOS35118351182020-04-01
00609038351193AVANOS35119351192020-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08809040526776Air Relax Classic Model AR-1.0 ControlUnit OnlyMaxstar Industrial Co.,Ltd.IRP2025-10-01
08809040526783Air Relax Classic Model AR-1.0 Leg Recovery System-Size 2Maxstar Industrial Co.,Ltd.IRP2025-10-01
08809040526790Air Relax Classic Model AR-1.0 Leg Recovery System-Size 3Maxstar Industrial Co.,Ltd.IRP2025-10-01
08809040526806Air Relax Classic Model AR-1.0 Leg Recovery System-Size 4Maxstar Industrial Co.,Ltd.IRP2025-10-01
08809643652087CERAGEM Master V9CERAGEM Co., Ltd.IRP2025-07-15
08809494000686CERAGEM Master V7CERAGEM Co., Ltd.IRP2025-02-12
08809494000983CERAGEM Master V7CERAGEM Co., Ltd.IRP2025-02-12
08809315676984LF900DAESUNG MAREF CO.,LTD.IRP2023-03-08
08809277423466WONJINWONJIN MULSAN CO.LTDIRP2022-01-11
088098026404054 chamber sleeveDAESUNG MAREF CO.,LTD.IRP2021-12-22
08809315672252SP-2000DAESUNG MAREF CO.,LTD.IRP2021-12-17
08809315672269SP-2000DAESUNG MAREF CO.,LTD.IRP2021-12-17
08809315672276SP-2000DAESUNG MAREF CO.,LTD.IRP2021-12-17
08809315672283SP-2000DAESUNG MAREF CO.,LTD.IRP2021-12-17
08809315672290SP-2000DAESUNG MAREF CO.,LTD.IRP2021-12-17
08809315672306SP-2000DAESUNG MAREF CO.,LTD.IRP2021-12-17
08809315672375SP-2000DAESUNG MAREF CO.,LTD.IRP2021-12-17
08809315672382SP-2000DAESUNG MAREF CO.,LTD.IRP2021-12-17
08809315672399SP-2000DAESUNG MAREF CO.,LTD.IRP2021-12-17
08809315672405SP-2000DAESUNG MAREF CO.,LTD.IRP2021-12-17
08809315672412SP-2000DAESUNG MAREF CO.,LTD.IRP2021-12-17
08809802640221LF400DAESUNG MAREF CO.,LTD.IRP2021-12-17
088098026403754 chamber sleeveDAESUNG MAREF CO.,LTD.IRP2021-12-17
088098026403824 chamber sleeveDAESUNG MAREF CO.,LTD.IRP2021-12-17
088098026403994 chamber sleeveDAESUNG MAREF CO.,LTD.IRP2021-12-17
088098026404124 chamber sleeveDAESUNG MAREF CO.,LTD.IRP2021-12-17