DEVICE: BRYDAN MEDICAL (00863574000452)

Device Identifier (DI) Information

BRYDAN MEDICAL
12204
In Commercial Distribution

BRYDAN MEDICAL HOLDINGS
00863574000452
GS1

1
078612438 *Terms of Use
Bariatric Walkeradj height: 32' - 38-1/2
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Device Characteristics

MR Conditional
No
No
No
No
No
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?
37952 Bariatric walker, foldable
An all- or partially-wheeled mobility aid in the form of a waist-high, foldable, extra wide framework with handgrips and four legs designed to provide a stable support for a bariatric (obese) person when standing or ambulating; it may also be used during rehabilitation. It is a sturdy construction made of lightweight metal, plastic, and rubber materials that surrounds the front and flanks of the user. The user holds the handgrips to push the device in front of them as they move forward. The device is foldable for storage and transportation, and includes a braking mechanism; it may be width-adjustable.
Obsolete false
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FDA Product Code

[?]
Product Code Product Code Name
ITJ Walker, 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

e317823a-48e1-41e9-9453-85194895d731
October 05, 2018
3
December 29, 2017
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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

[?]
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)

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

[?]
No
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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