DEVICE: Game Ready Med4 Elite Drain Hose (00812120002662)
Device Identifier (DI) Information
Game Ready Med4 Elite Drain Hose
573240
In Commercial Distribution
573240
Avanos Medical, Inc.
573240
In Commercial Distribution
573240
Avanos Medical, Inc.
Drain Hose Kit MED4 Elite (Qty 2)
Device Characteristics
Labeling does not contain MRI Safety Information | |
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Yes | |
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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? |
---|---|---|---|---|
60708 | Circulating-fluid localized thermal/compression therapy system wrap |
A 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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
IRP | Massager, powered inflatable tube |
ILO | Pack, hot or cold, water circulating |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K171685 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
a2ce08fa-119a-46f1-9ca1-fedfe8951430
December 18, 2023
2
April 05, 2023
December 18, 2023
2
April 05, 2023
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 |
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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