Duns Number:078572603
Device Description: Single Patient Use Sphygmomanometer, Latex Free, Large Adult
Catalog Number
-
Brand Name
HCS
Version/Model Number
HCS9016
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K942543,K942543
Product Code
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
5d646db8-4c87-467d-ab32-d786248c0c13
Public Version Date
December 14, 2020
Public Version Number
3
DI Record Publish Date
January 13, 2017
Package DI Number
10849027002348
Quantity per Package
50
Contains DI Package
00849027002341
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 | 72 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 30 |