AccessGUDID - DEVICE: Midmark (00841709106064)

GUDID

Device Identifier (DI) Information

Brand Name: Midmark
Version or Model: 604 Manual Examination Table
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 604-001
Company Name: MIDMARK CORPORATION

Primary DI Number: 00841709106064
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005036025 *Terms of Use

Device Description: The Midmark 604 Manual Examination Table is intended to be used as a table to provide positioning and support of patients during examination procedures conducted by qualified medical professionals in an 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?
38458	Examination/treatment table, manual	A non-mobile table designed for routine/minor medical examinations and/or treatment of the patient. It will typically consist of a framework with a flat table top surface which may have a head section that can be manually adjusted into a raised position. The height of the table may also be manually adjusted to fixed positions (i.e., set to an initial height but not readily adjustable). It may facilitate a paper roll holder from which paper is pulled to cover the table surface as a hygienic barrier for each new patient. This device is typically used in examination rooms or doctors' surgeries as a statically placed table.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRK	CHAIR, EXAMINATION AND TREATMENT

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 500 and 1060 KiloPascal
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 500 and 1060 KiloPascal
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between -5 and 38 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4aa17349-80e8-4246-bf83-c0671c30aa11
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: November 14, 2017