Duns Number:315304071
Device Description: SUCTION PUMP for US Litho 2271, with speed control for pressure setting between 0.1 and 0 SUCTION PUMP for US Litho 2271, with speed control for pressure setting between 0.1 and 0.6 bar, U: 100-230VAC/ 50/60Hz, Dim. (wxhxd): 320x120x225mm
Catalog Number
2207.011
Brand Name
NA
Version/Model Number
2207011
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"
-
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
JCX
Product Code Name
APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
Public Device Record Key
c33e1367-f85b-49ae-ad36-070507f48269
Public Version Date
December 24, 2018
Public Version Number
4
DI Record Publish Date
July 21, 2017
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 | 587 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1835 |