Duns Number:132016168
Device Description: Deluxe Aneroid Blood Pressure Monitor
Catalog Number
-
Brand Name
LUMISCOPE
Version/Model Number
100-510LA
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
8963d56a-a45e-4014-857e-cbb3cea3272a
Public Version Date
July 25, 2019
Public Version Number
4
DI Record Publish Date
August 31, 2016
Package DI Number
M368100510LA2
Quantity per Package
24
Contains DI Package
M368100510LA1
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1068 |
2 | A medical device with a moderate to high risk that requires special controls. | 202 |