Midmark

Basic Information

• Brand Name: Midmark
• Primary DI: 00841709108396
• Version / Model: P32/P5
• Catalog Number: P32/P5
• Company Name: MIDMARK CORPORATION
• Labeler DUNS: 005036025
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-02-08
• Public Version: 1
• Public Version Date: 2019-03-11
• Public Version Status: New
• Public Device Record Key: 96693f56-466d-42b1-bbbb-4dc1a0ff44e8

Device Description

Midmark PowerAir Oil-Less Compressors are intended to provide compressed air during general examinations and procedures conducted by qualified dental professionals. Model: P32, Number of users: 3 - 5, Number of heads: 3, Total HP: 2.25, CFM @ 80psi: 7.8, Voltage: 208 - 230. Midmark PowerVac Dry vacuums are intended to provide suction during general examinations and procedures conducted by qualified dental professionals. Model: P5, Number of users: 5 - 7, Number of vacuums: 1, Total HP: 2.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NRD	Unit, operative dental, accessories	Dental	872.6640	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34859	Dental suction system	An assembly of devices designed to aspirate water, blood, saliva, and tooth debris from the oral cavity by means of suction, to maintain a clear operative site during dental surgical, professional hygiene, and orthodontic procedures. It consists of an electrically-powered suction pump with a control knob and patient contact devices (typically suction handpiece/tip); collection containers, spittoon, tubing, and amalgam separator are also often included.	No	Active
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841709108396	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 10 – 37 Degrees Celsius
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Handling Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 10 – 37 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal