Duns Number:537208717
Device Description: Aneroid sphygmomanometers for non invasive measurement of arterial blood pressure.
Catalog Number
1376-109
Brand Name
e-mega black adult size velcro cuff, double tube
Version/Model Number
1376-109
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
-
Product Code
DXQ
Product Code Name
Blood Pressure Cuff
Public Device Record Key
d2302542-c269-4c2b-afdf-e4d19b293143
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 30, 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 | 282 |
2 | A medical device with a moderate to high risk that requires special controls. | 332 |