Duns Number:544423370
Device Description: Dark blue nylon, Bladderless, Single tube, With connector Large Adult Long Range 35.5-59cm
Catalog Number
-
Brand Name
Orantech
Version/Model Number
BPN-80NS-W01M
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K173197
Product Code
DXQ
Product Code Name
Blood Pressure Cuff
Public Device Record Key
640b8037-daac-4cd4-9777-f96bb2f9d65e
Public Version Date
October 24, 2022
Public Version Number
1
DI Record Publish Date
October 16, 2022
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 | 158 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1473 |