DEVICE: CVS Health (00050428414590)
Device Identifier (DI) Information
CVS Health
275172
In Commercial Distribution
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
275172
In Commercial Distribution
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Body Analysis Scale
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Bioelectrical body composition analyser | An electronic device designed to estimate body composition (i.e., percent body fat, lean, bone, and/or hydration) with regards to bioelectrical impedance analysis (BIA) and often personal characteristics (e.g., age, gender, height, weight). It may be in the form of a unit with electrodes applied to the surface of the patient’s body, or a scale(s) placed on the floor and upon which the patient stands to measure total body weight. Both types perform BIA by passing a low electrical current through the body; personal characteristics may be manually entered. Data are analysed to provide measurements that may include body mass index (BMI), fat/muscle/bone mass, and total body water percent. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
PUH | Analyzer, Body Composition, Exempt |
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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Storage Environment Humidity: between 20 and 95 Percent (%) Relative Humidity |
Storage Environment Temperature: between -20 and 60 Degrees Celsius |
Handling Environment Humidity: between 25 and 85 Percent (%) Relative Humidity |
Handling Environment Temperature: between 0 and 40 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
3f99f6bb-23e3-4e4f-86a6-600f36e501f0
August 14, 2018
3
October 11, 2016
August 14, 2018
3
October 11, 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 |
---|---|---|---|---|---|
10050428414597 | 4 | 00050428414590 | In Commercial Distribution | Case 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
[?]
1-800-536-0366
info@beurer.com
info@beurer.com