DEVICE: GAME READY* Med4 Elite* Accessory Kit (00812120004451)
Device Identifier (DI) Information
GAME READY* Med4 Elite* Accessory Kit
303945-PB07
In Commercial Distribution
303945-PB07
Avanos Medical, Inc.
303945-PB07
In Commercial Distribution
303945-PB07
Avanos Medical, Inc.
GAME READY* Med4 Elite* Accessory Kit - BR, PT
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
60707 | Circulating-fluid localized thermal/compression therapy system control unit |
An electrically-powered device intended to pump heated and/or cooled water through an externally applied wrap (not included), and to air inflate the wrap, for localized thermal and compression therapy to facilitate the treatment of a variety of adverse conditions resulting from musculoskeletal injury and/or orthopaedic surgery (e.g., pain, swelling, inflammation). It includes a fluid pump, air pump, controls, and either a heater or a means for cold therapy (e.g., refrigeration unit, addition of independently cooled ice water) or both. The unit may be programmable for selected treatment plans. It is intended for use in both professional and home settings.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
ILO | Pack, hot or cold, water circulating |
IRP | Massager, powered inflatable tube |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K171685 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
342554f4-3aaa-4328-b715-8831bb54dba8
November 07, 2024
1
October 30, 2024
November 07, 2024
1
October 30, 2024
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(844)428-2667
PIQ@AVANOS.COM
PIQ@AVANOS.COM