AccessGUDID - DEVICE: Setmark Incorporated (00854204008047)

GUDID

Device Identifier (DI) Information

Brand Name: Setmark Incorporated
Version or Model: TR-136
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SETMARK INC.

Primary DI Number: 00854204008047
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080798558 *Terms of Use

Device Description: Bariatric Walker: adj height: 32" - 38-1/2"

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

FDA Product Code

[?]

Product Code	Product Code Name
ITJ	Walker, Mechanical

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e1c1da7c-da9e-4605-a677-5a0db3ab909d
Public Version Date: October 05, 2018
Public Version Number: 3
DI Record Publish Date: January 31, 2018

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

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

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

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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