Duns Number:031284586
Device Description: The Flow COUPLER Monitor is a pulsed Doppler ultrasound system designed to detect vessel b The Flow COUPLER Monitor is a pulsed Doppler ultrasound system designed to detect vessel blood flow and confirm vessel patency intra and post-operatively at the anastomotic site as needed up to 7 days.
Catalog Number
515600000011
Brand Name
GEM FLOW COUPLER MONITOR
Version/Model Number
GEM1020M-2
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"
-
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
K191252
Product Code
DPW
Product Code Name
FLOWMETER, BLOOD, CARDIOVASCULAR
Public Device Record Key
e0b02bc7-559f-4eff-b7ab-050ebdba3488
Public Version Date
October 11, 2022
Public Version Number
5
DI Record Publish Date
September 30, 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 | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 55 |