DEVICE: PLUS (05708590376844)

Device Identifier (DI) Information

PLUS
R7864
In Commercial Distribution
R7864000
Pressalit A/S
05708590376844
GS1

1
305656662 *Terms of Use
PLUS shower seat 450, 17.7'' x 17.2'', incl. backrest and armrests, white. Electrically height adjustable, manually sideways adjustable, for fitting to horizontal wall track
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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. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
63008 Shower seat, power-adjusted
An electrically-powered device designed to be sat upon by a patient (adult or child) while washing in a bath, shower, or other washing facility. The patient is typically disabled, infirm, or is undergoing medical treatment and requires to be seated while bathing/showering. The device is typically in the form of a fixed seat (e.g., wall-mounted) with powered controls to adjust position (typically height), and may include armrests, side supports, or grab handles; it is typically made of water-resistant or waterproof materials. It may be used in a hospital, institution, or home.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
INN Chair, Adjustable, Mechanical
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes 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

a7d08f06-10ba-4ea0-8739-58bc5276a6f6
June 22, 2021
1
June 14, 2021
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
+4587888788
pressalit@pressalit.com
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