Duns Number:005036025
Device Description: Midmark PowerAir Oil-Less Compressors, with sound cover, are intended to provide compresse Midmark PowerAir Oil-Less Compressors, with sound cover, are intended to provide compressed air during general examinations and procedures conducted by qualified dental professionals. Model: P52SC, Number of users: 5 - 7, Number of heads: 2, Total HP: 3.2, CFM @ 80psi: 10.6, Voltage: 208 - 230.Midmark PowerVac Dry vacuums are intended to provide suction during general examinations and procedures conducted by qualified dental professionals. Model: P6, Number of users: 6 - 10, Number of vacuums: 2, Total HP: 4.
Catalog Number
P52SC/P6
Brand Name
Midmark
Version/Model Number
P52SC/P6
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NRD
Product Code Name
Unit, operative dental, accessories
Public Device Record Key
53ac5af8-e143-4e6b-92c3-4a4e7f663b5a
Public Version Date
March 11, 2019
Public Version Number
1
DI Record Publish Date
February 08, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 838 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 544 |