Duns Number:079428290
Device Description: The Reusable Accuryn Temperature Cable is an accessory that connects to a temperature-sens The Reusable Accuryn Temperature Cable is an accessory that connects to a temperature-sensing Foley catheter's thermistor plug and temperature port on the Accuryn Monitor for continuous temperature measurement.
Catalog Number
FGN-06-100779
Brand Name
Accuryn Temperature Cable
Version/Model Number
FGN-06-100779
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
K153655
Product Code
EXY
Product Code Name
Uroflowmeter
Public Device Record Key
eff0f04f-0239-4781-8d3d-fd984489e19d
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 |