DEVICE: ManaMed (00810113682594)

Device Identifier (DI) Information

ManaMed
ManaCold Platinum Univeral Combo Unit
In Commercial Distribution
MANACOLD01-PT
Manamed, Inc.
00810113682594
GS1

1
084042331 *Terms of Use
ManaCold Platinum Water Circulating Therapy Device is used decrease pain, swelling, and muscle spasms after surgery or injury. ManaCold consists of a cold water circulating unit, a 9 quart cooling reservoir with a lid, 7 foot insulation tube and a cold therapy pad. The cold therapy pad is applied to a patients injured area, delivering cold therapy through the tubing and into the cold pad. Commonly used following knee surgery, shoulder surgery or back surgery ManaCold can be used and operated by a patient or healthcare provider in a home or clinical setting
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
No
Yes
No
No
Yes
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?
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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32965 Circulating-fluid localized thermal therapy system pack, reusable
A device intended to be applied to part of the body as part of a circulating-fluid localized thermal therapy system to provide localized heat and/or cold therapy for the skin and/or underlying tissues (e.g., muscle) in the treatment of musculoskeletal pain and discomfort. It typically consists of a compact envelope that is heated and/or cooled with circulating fluid (e.g., water) from the system control unit. It is intended for use in both professional and home settings. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
ILO Pack, Hot Or Cold, Water Circulating
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

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

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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

39e7d506-9d1a-4847-a3a9-213b5d1d0adf
July 11, 2024
3
October 31, 2022
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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

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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
Yes
No
Yes
No CLOSE

Customer Contact

[?]
888-508-0712
support@manamed.com
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