DEVICE: BREG (00672736021446)
Device Identifier (DI) Information
BREG
NOVAPLUS PC CUBE W/ KNEE PAD
In Commercial Distribution
V10705
BREG, INC.
NOVAPLUS PC CUBE W/ KNEE PAD
In Commercial Distribution
V10705
BREG, INC.
1 Ice Water Container, 1 6 VDC output, 120 VAC 60 Hz input transformer and 1 04700 WO Knee Polar Pad
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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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42463 | Circulating-fluid localized thermal therapy system control unit |
An electrically-powered device intended to be used as part of a localized circulating-fluid thermal therapy system to pump heated and/or cooled fluid (e.g., water) through an externally applied pack (not included) for localized hot and/or cold therapy for the skin and/or underlying tissues (e.g., muscle) in the treatment of musculoskeletal pain and discomfort. It includes a fluid pump and either a heater, or a means for cold therapy (e.g., refrigeration unit, permitting addition of independently cooled ice water) or both; it does not include an air pump for wrap inflation. It is intended for use in both professional and home settings.
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61429 | Inflatable hot/cold therapy pack/electric pump |
A non-sterile assembly of devices intended for localized thermal and compression therapy to facilitate the treatment of 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 with an air inflation sleeve, a mains electricity (AC-powered) air pump with controls, and air-conduction tubing; the pack(s) is heated/cooled independently of the system (e.g., cooled using chilling unit) and may be anatomically specific. The unit may be programmed for selected treatment plans. 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 |
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ILO | Pack, Hot Or Cold, Water Circulating |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
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
85e9afed-fee7-4bba-9237-a4ecb85cc031
December 18, 2023
4
August 15, 2016
December 18, 2023
4
August 15, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
20672736021464 | 4 | 00672736021446 | In Commercial Distribution | Bulk 4 pack |
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
[?]
8003210607
xx@xx.xx
xx@xx.xx