DEVICE: Freedom Bath (05055982705127)

Device Identifier (DI) Information

Freedom Bath
AF21104US01
In Commercial Distribution

Arjohuntleigh AB
05055982705127
GS1

1
355804758 *Terms of Use
Bath System - Freedom Bath, LA, Still bath
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
Yes
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
41576 Walk-in bathtub
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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
ILJ Bath, hydro-massage
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

62133b72-4234-4588-8c3a-b890ae8c9270
June 10, 2022
3
October 28, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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