Duns Number:544392778
Catalog Number
-
Brand Name
Verature
Version/Model Number
DBP-1332
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 19, 2019
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
26f6761d-a079-441a-8eef-084c3bc10f75
Public Version Date
December 27, 2019
Public Version Number
1
DI Record Publish Date
December 19, 2019
Package DI Number
26970392213631
Quantity per Package
24
Contains DI Package
06970392213637
Package Discontinue Date
December 04, 2019
Package Status
Not in Commercial Distribution
Package Type
carton
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 36 |