GAME READY* MED4 Elite* Control Unit 650500

GUDID 00812120004208

GAME READY* MED4 Elite* Control Unit

Avanos Medical, Inc.

Circulating-fluid localized thermal/compression therapy system control unit
Primary Device ID00812120004208
NIH Device Record Key589a8b7a-5091-42da-835f-69ddbabf5583
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100812120004208 [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 Date2024-11-07
Device Publish Date2024-10-30

Devices Manufactured by Avanos Medical, Inc.

10350770005604 - CORGRIP* SR NG/NI Tube Retention System2024-11-14 CORGRIP* SR Nasogastric/Nasointestinal Feeding Tube Retention System
10350770005611 - CORGRIP* SR NG/NI Tube Retention System2024-11-14 CORGRIP* SR Nasogastric/Nasointestinal Feeding Tube Retention System
10350770005628 - CORGRIP* SR NG/NI Tube Retention System2024-11-14 CORGRIP* SR Nasogastric/Nasointestinal Feeding Tube Retention System
10350770005635 - CORGRIP* SR NG/NI Tube Retention System2024-11-14 CORGRIP* SR Nasogastric/Nasointestinal Feeding Tube Retention System
10350770005642 - CORGRIP* SR NG/NI Tube Retention System2024-11-14 CORGRIP* SR Nasogastric/Nasointestinal Feeding Tube Retention System
10350770005659 - CORGRIP* SR NG/NI Tube Retention System2024-11-14 CORGRIP* SR Nasogastric/Nasointestinal Feeding Tube Retention System
00812120004208 - GAME READY* MED4 Elite* Control Unit2024-11-07GAME READY* MED4 Elite* Control Unit
00812120004208 - GAME READY* MED4 Elite* Control Unit2024-11-07 GAME READY* MED4 Elite* Control Unit
00812120004246 - Med4Elite Accessories2024-11-07 GAME READY* Med4 Elite* Accessory Kit - NA, GB

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.