Duns Number:078803608
Device Description: STANDARD ANEROID BP-ROY-BX
Catalog Number
-
Brand Name
Aneroids (82 etc.)
Version/Model Number
79-ROY
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
Product Code
DXQ
Product Code Name
Blood Pressure Cuff
Public Device Record Key
5567deed-e857-4c48-806a-3c9a3e065612
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 07, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
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. | 633 |