Game Ready Med4 Elite Control Unit 650500

GUDID 00812120003355

Control Unit MED4 Elite Final Assembly

Avanos Medical, Inc.

Circulating-fluid thermal/compression therapy system control unit Circulating-fluid thermal/compression therapy system control unit Circulating-fluid thermal/compression therapy system control unit Circulating-fluid thermal/compression therapy system control unit Circulating-fluid thermal/compression therapy system control unit Circulating-fluid thermal/compression therapy system control unit Circulating-fluid thermal/compression therapy system control unit Circulating-fluid thermal/compression therapy system control unit Circulating-fluid thermal/compression therapy system control unit Circulating-fluid thermal/compression therapy system control unit Circulating-fluid thermal/compression therapy system control unit Circulating-fluid thermal/compression therapy system control unit Circulating-fluid thermal/compression therapy system control unit Circulating-fluid thermal/compression therapy system control unit Circulating-fluid thermal/compression therapy system control unit Circulating-fluid thermal/compression therapy system control unit Circulating-fluid thermal/compression therapy system control unit Circulating-fluid thermal/compression therapy system control unit Circulating-fluid localized thermal/compression therapy system control unit Circulating-fluid localized thermal/compression therapy system control unit Circulating-fluid localized thermal/compression therapy system control unit Circulating-fluid localized thermal/compression therapy system control unit Circulating-fluid localized thermal/compression therapy system control unit Circulating-fluid localized thermal/compression therapy system control unit Circulating-fluid localized thermal/compression therapy system control unit Circulating-fluid localized thermal/compression therapy system control unit Circulating-fluid localized thermal/compression therapy system control unit Circulating-fluid localized thermal/compression therapy system control unit Circulating-fluid localized thermal/compression therapy system control unit Circulating-fluid localized thermal/compression therapy system control unit Circulating-fluid localized thermal/compression therapy system control unit Circulating-fluid localized thermal/compression therapy system control unit Circulating-fluid localized thermal/compression therapy system control unit Circulating-fluid localized thermal/compression therapy system control unit
Primary Device ID00812120003355
NIH Device Record Keya72d5fff-fe55-408a-b0a6-3f8a535beab1
Commercial Distribution StatusIn Commercial Distribution
Brand NameGame Ready Med4 Elite Control Unit
Version Model Number650500
Catalog Number650500
Company DUNS079375431
Company NameAvanos Medical, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS100812120003355 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ILOPack, hot or cold, water circulating

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-04-13
Device Publish Date2023-04-05

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