Duns Number:002034635
Device Description: Wall Aneroid Large Arm Non-Latex Calibrated V-Lok Inflation System & Basket
Catalog Number
0955NL
Brand Name
BAUM
Version/Model Number
0955NL
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
-
Product Code
DXN
Product Code Name
System, measurement, blood-pressure, non-invasive
Public Device Record Key
ddeb5262-dfbd-4951-a6a9-4faf74f5c46e
Public Version Date
October 09, 2019
Public Version Number
1
DI Record Publish Date
October 01, 2019
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 465 |