AccessGUDID - DEVICE: Midmark (00841709106682)

GUDID

Device Identifier (DI) Information

Brand Name: Midmark
Version or Model: 646-001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 646-001
Company Name: MIDMARK CORPORATION

Primary DI Number: 00841709106682
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005036025 *Terms of Use

Device Description: This power procedures chair is intended to be used as a chair / table to provide positioning and support for patients during examinations and procedures conducted by qualified medical professionals (primarily podiatrists).

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?
47150	Podiatric chair, electric	A mains electricity (AC-powered) device designed to support a patient in a seated position and to facilitate foot examination, treatment, and/or minor surgery procedures. It is typically adjustable in height and includes armrests and a reclining back that may be tilted from a vertical to a horizontal position. It usually includes individual leg sections and footrests with lifting and rotating capabilities; some types can be programmed to several standard positions. Devices intended for foot examination and/or treatment may be attached as components of the chair (and may be operated using the chair controls), or stand separately as self-supported or wall-mounted units.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GBB	CHAIR, SURGICAL, AC-POWERED

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
Storage Environment Temperature: between 5 and 38 Degrees Celsius
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Handling Environment Temperature: between 5 and 38 Degrees Celsius
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ba56b1ac-9dce-4f71-964a-d36480a86c33
Public Version Date: May 05, 2020
Public Version Number: 2
DI Record Publish Date: March 26, 2018