Duns Number:054318779
Device Description: Aneroid Sphygmomanometer with Blue Nylon Cuff
Catalog Number
-
Brand Name
Aneroid Sphygmomanometer
Version/Model Number
11-200
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K780715,K780715,K780715
Product Code
DXQ
Product Code Name
Blood Pressure Cuff
Public Device Record Key
a11fdc68-bbd7-4a0e-bf38-f1de4403548c
Public Version Date
October 13, 2020
Public Version Number
4
DI Record Publish Date
September 16, 2016
Package DI Number
10073796112001
Quantity per Package
50
Contains DI Package
00073796112004
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 48 |