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.
00812120004451
GS1

1
079375431 *Terms of Use
GAME READY* Med4 Elite* Accessory Kit - BR, PT
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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
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FDA Product Code

[?]
Product Code Product Code Name
ILO Pack, hot or cold, water circulating
IRP Massager, powered inflatable tube
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K171685 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

342554f4-3aaa-4328-b715-8831bb54dba8
November 07, 2024
1
October 30, 2024
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
+1(844)428-2667
PIQ@AVANOS.COM
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