DEVICE: Imp DF50 (B277249DF500)
Device Identifier (DI) Information
Imp DF50
DF50
Not in Commercial Distribution
229-DF50
IMPEDIMED LIMITED
DF50
Not in Commercial Distribution
229-DF50
IMPEDIMED LIMITED
DF50 Single Frequency Bioimpedance; A bioimpedance (BIA) device to aid in the clinical assessment of fluid status and body composition by a healthcare professional in healthy individuals.
ROW Refurbished Device
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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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36022 | 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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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MNW | Analyzer, Body Composition |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K050395 | 000 |
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
a4fab8a8-ef23-4984-849f-bd85bd8b53f3
July 06, 2018
3
February 13, 2017
July 06, 2018
3
February 13, 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 |
---|---|---|---|---|---|
B277249DF502 | 1 | B277249DF501 | 2017-02-13 | Not in Commercial Distribution | Shipper |
B277249DF501 | 1 | B277249DF500 | 2017-02-13 | Not in Commercial Distribution | Soft Carry Case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined