DEVICE: Kelvi (00850001185059)
Device Identifier (DI) Information
Kelvi
KLV20004
In Commercial Distribution
HYPOTHERMIA DEVICES, INC.
KLV20004
In Commercial Distribution
HYPOTHERMIA DEVICES, INC.
Kelvi Ankle Pro Smart Wrap
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? |
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62442 | Circulating-fluid localized thermal therapy system |
An assembly of devices intended to be used to pump heated and/or cooled fluid (e.g., water) through externally applied packs for localized hot and/or cold therapy to help treat a variety of adverse conditions resulting from musculoskeletal injury (e.g., pain, swelling, inflammation). It includes one or more hot and/or cold therapy packs (e.g., anatomically specific wraps), and a mains electricity (AC-powered) fluid pump and heating/cooling unit with controls/display; the device is not intended for wrap inflation. It is intended for use in both professional and home settings.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
ILO | Pack, Hot Or Cold, Water Circulating |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 1 and 52 Degrees Celsius |
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
c41bef67-9503-45e6-bd2e-dfc8ca1047ff
December 18, 2023
2
June 17, 2019
December 18, 2023
2
June 17, 2019
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
[?]
3104925886
info@kelvi.com
info@kelvi.com