Duns Number:105932508
Device Description: Optimum Aneroid Sphygmomanometer, Black Nylon Cuff, Large Adult, Latex Free
Catalog Number
-
Brand Name
BV Medical
Version/Model Number
20-108-015-L
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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"
Yes
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
DXQ
Product Code Name
Blood Pressure Cuff
Public Device Record Key
ed79e993-da3f-42f8-aa3d-26ecb3cb1c72
Public Version Date
June 04, 2018
Public Version Number
3
DI Record Publish Date
December 09, 2016
Package DI Number
00845821027689
Quantity per Package
50
Contains DI Package
00845821030665
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 | 658 |
2 | A medical device with a moderate to high risk that requires special controls. | 163 |