AccessGUDID - DEVICE: Midmark (00841709121449)

GUDID

Device Identifier (DI) Information

Brand Name: Midmark
Version or Model: P52-050
Commercial Distribution Status: In Commercial Distribution
Catalog Number: P52-050
Company Name: MIDMARK CORPORATION

Primary DI Number: 00841709121449
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005036025 *Terms of Use

Device Description: Midmark Smart Air Compressors are intended to provide compressed air during general examinations and procedures conducted by qualified dental professionals. Model: P52-050, Number of users: 5 - 7, Number of heads: 2, Total HP: 3.2, CFM @ 80psi: 10.6, Voltage: 230.

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?
31253	Medical device air compressor	A mains electricity (AC-powered) device designed to create compressed air and supply it directly to gas-powered or compressed air dependent devices (e.g., ventilators or other respiratory devices, laboratory equipment). It may also provide medical air depending upon the filtering systems employed.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NRD	Unit, operative dental, accessories

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 Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Temperature: between 4 and 37 Degrees Celsius
Handling Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Handling Environment Temperature: between 4 and 37 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 017f3d1f-b00f-455b-9fda-5a97d776f687
Public Version Date: April 30, 2024
Public Version Number: 1
DI Record Publish Date: April 22, 2024