AccessGUDID - DEVICE: Evolution (00860010555613)

GUDID

Device Identifier (DI) Information

Brand Name: Evolution
Version or Model: S-250
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: L.P.A. Médical Inc

Primary DI Number: 00860010555613
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 245321237 *Terms of Use

Device Description: Evolution tilt-in-space pedal chair with central push-rims

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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":	Yes
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?
38704	Walking chair, non-foldable	An all-wheeled mobility aid in the form of a non-foldable framework that has a built-in seat or sling that supports a disabled or geriatric person in a sitting position while walking. It is constructed of lightweight metal, plastic, rubber and textile materials in the shape of a low centre-of-gravity mobile support structure in which the user walks while seated. The device is non-foldable and may include forearm supports and a braking mechanism.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
INM	Chair, With Casters

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: 4d304077-99bc-42a0-b981-824c17caa3c6
Public Version Date: June 26, 2023
Public Version Number: 1
DI Record Publish Date: June 17, 2023

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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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