DEVICE: Freedom Bath (05055982702744)
Device Identifier (DI) Information
Freedom Bath
AF11000US11
In Commercial Distribution
Arjohuntleigh AB
AF11000US11
In Commercial Distribution
Arjohuntleigh AB
Bath System - Freedom Bath, Std, Still bath
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Walk-in bath | A bathing (washing) receptacle designed to accommodate a patient's full body and entered by the patient through normal walking (i.e., without need to lift or swing the legs high). It may be constructed so that one side is lowered, swung open, or removed to facilitate entry; the patient easily steps or sits into the bath before the side is closed/replaced. The device is intended to enable a geriatric, infirm, or disabled patient easy access for bathing. It may have added features such as a water mixing battery with temperature control. |
FDA Product Code
[?]Product Code | Product Code Name |
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ILJ | Bath, hydro-massage |
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
d46272d0-1303-4bab-92e7-ffdbc05d1888
March 29, 2018
2
October 26, 2016
March 29, 2018
2
October 26, 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 |
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No Package DIs found |
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
[?]
No Customer Contact currently defined