Duns Number:079428290
Device Description: The Accuryn Monitor High Mount & Floor Stand is a set consisting of one Accuryn Monitor Hi The Accuryn Monitor High Mount & Floor Stand is a set consisting of one Accuryn Monitor High Mount and one Accuryn Monitor Floor Stand. The Accuryn Monitor High Mount & Floor Stand is an accessory to the Accuryn Monitoring System.
Catalog Number
FGN-06-102111
Brand Name
Accuryn Monitor High Mount & Floor Stand
Version/Model Number
FGN-06-102111
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"
-
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
K153655
Product Code
EXY
Product Code Name
Uroflowmeter
Public Device Record Key
435d62bd-2813-4f33-8038-d9130883c37b
Public Version Date
October 27, 2022
Public Version Number
1
DI Record Publish Date
October 19, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 16 |