Duns Number:848429929
Device Description: Non-invasive Blood Pressure Hose, 3 meter. Female HP Connectors.
Catalog Number
180-1014
Brand Name
NA
Version/Model Number
NIBP Hose, 3 meter
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K130740
Product Code
DXQ
Product Code Name
Blood Pressure Cuff
Public Device Record Key
55890414-b6d3-46c1-983e-a678ddb2f3f6
Public Version Date
July 22, 2019
Public Version Number
4
DI Record Publish Date
September 22, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 45 |