Duns Number:062028220
Device Description: CUFF & BLADDER 2-TUBE BLUE NYLON LARGE ADULT
Catalog Number
05-260-016
Brand Name
MABIS
Version/Model Number
05-260-016
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
K942543,K942543
Product Code
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
307d578e-2323-444f-88f5-62cbe7b1e775
Public Version Date
December 14, 2020
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
10767056601618
Quantity per Package
75
Contains DI Package
00767056600164
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1 |
2 | A medical device with a moderate to high risk that requires special controls. | 206 |