Duns Number:105932508
Device Description: Basic Series Aneroid Sphygmomanometer, Black Nylon Cuff, Child, Latex Free
Catalog Number
-
Brand Name
BV Medical
Version/Model Number
20-100-013-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
K092245,K092245
Product Code
DXQ
Product Code Name
Blood Pressure Cuff
Public Device Record Key
f8c6ec8d-4562-435e-917a-85836f8fff62
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 09, 2016
Package DI Number
00845821027634
Quantity per Package
50
Contains DI Package
00845821000972
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 |