AccessGUDID - DEVICE: MERITS (04714379296921)

GUDID

Device Identifier (DI) Information

Brand Name: MERITS
Version or Model: P335 30200724
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MERITS HEALTH PRODUCTS CO., LTD.

Primary DI Number: 04714379296921
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 657231924 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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?
38529	Wheelchair, power-assisted, occupant-controlled, non-collapsible	A wheeled personal mobility device that incorporates a seat-support system for a person with a disability or a person without the full capacity to walk (not bariatric) designed to be manually propelled and steered by the rotation of both rear wheels by the occupant, and when needed, power from an electric motor replaces manual wheel rotation. The device cannot be folded or readily dismantled for transport. Typically, the user is a paraplegic or quadriparetic person who desires to manually propel himself as much as possible for the exercise. The power assist feature is enabled to climb inclines, for extended distance travel, or when the user fatigues.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
ITI	Wheelchair, Powered

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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: 48664540-4483-43de-84a0-2ff1206d977e
Public Version Date: August 23, 2022
Public Version Number: 1
DI Record Publish Date: August 15, 2022

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: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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