AccessGUDID - DEVICE: Midmark (00841709106484)

GUDID

Device Identifier (DI) Information

Brand Name: Midmark
Version or Model: 630-012
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 630-012
Company Name: MIDMARK CORPORATION

Primary DI Number: 00841709106484
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005036025 *Terms of Use

Device Description: This procedures table is intended to be used as a chair / table to provide positioning and support of patients during general examinations and procedures conducted by qualified medical professionals in a medical office environment.

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?
38447	General examination/treatment chair, electric	A mains electricity (AC-powered) device designed to support and position the patient in a seated or reclined posture for easy access and patient comfort during a diagnostic examination, medical treatment, and/or surgical procedure across specialties. It usually has moveable components and may include special features such as a raising and lowering mechanism and removable arms; it may have an integrated weighing scale. For chairs involving the use of medical systems that emit and/or detect energy (e.g., ionizing or non-ionizing radiation, ultrasound, heat, light) see the respective chair terms for those systems.	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
Handling Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between -30 and 60 Degrees Celsius
Storage Environment Temperature: between -30 and 60 Degrees Celsius
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage 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: 51181b06-efe9-4031-879e-032fbd87da66
Public Version Date: October 13, 2021
Public Version Number: 3
DI Record Publish Date: May 03, 2018