Duns Number:062028220
Device Description: LATEX-FREE PRECISION ANEROID SPHYG W/NYLON CUFF BLUE CHILD
Catalog Number
09-141-015
Brand Name
MABIS
Version/Model Number
09-141-015
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
K082542,K082542
Product Code
DXQ
Product Code Name
Blood Pressure Cuff
Public Device Record Key
b0814547-52b2-4fee-9c0d-3a086a174be7
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
10767056410159
Quantity per Package
50
Contains DI Package
00767056410152
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 |