DEVICE: Mind+Body Care (00328785000238)
Device Identifier (DI) Information
Mind+Body Care
HEW3000
In Commercial Distribution
KAZ, INC.
HEW3000
In Commercial Distribution
KAZ, INC.
Mind+Body Care Spa WrapAround Pain relief for the Entire Body, 24" X 54”, 2 Hour auto shut-off, 10 foot cord. SmartHeat Technology with 3 heat settings.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
Yes | |
No | |
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No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Electric pad whole-body heating system pad | An electrically-heated underlay or overlay intended to provide heat under or over a patient as part of an electrical heating pad system used to heat a patient’s whole body (i.e., elevate core body temperature) typically in surgical and intensive care settings. The underlay/overlay typically contains electrical heating elements or cables supplied with energy by a dedicated control unit. The underlay/overlay is available in a variety of lengths, widths, and thicknesses to accommodate body size and application (e.g., adult/paediatric, full-/partial-body). This is a reusable device. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
IRT | Pad, Heating, Powered |
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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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
d18474fe-cc17-420b-aa60-c09eca42f48a
March 29, 2018
2
April 07, 2017
March 29, 2018
2
April 07, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10328785000235 | 9 | 00328785000238 | In Commercial Distribution | Case |
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
[?]
1-800-477-0457
consumerrelations@kaz.com
consumerrelations@kaz.com