AccessGUDID - DEVICE: Comp-Position (00860010555637)

GUDID

Device Identifier (DI) Information

Brand Name: Comp-Position
Version or Model: O-07
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: L.P.A. Médical Inc

Primary DI Number: 00860010555637
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 245321237 *Terms of Use

Device Description: Comp-Position height adjustable and width adjustable geriatric tilt-in-space chair

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?
58827	Assistive ergonomic chair, manually-adjusted	A non-electrical device, that may include pneumatically-assisted features, intended to support and position a patient (disabled and/or discomforted) in a sitting posture while performing activities of daily living, including work-related activities. It is designed with manually-operated ergonomic adjustments (e.g., height and position adjustments) to provide improved personal body posture and/or to help prevent/reduce physical problems associated with poor mobility or sedentary lifestyle. It is not a wheelchair.	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: 7e40ed0d-6316-4aee-bb9e-6a04381962f5
Public Version Date: June 26, 2023
Public Version Number: 1
DI Record Publish Date: June 17, 2023