Duns Number:031284586
Device Description: An external lead that joins the FLOW COUPLER probe to the FLOW COUPLER Monitor
Catalog Number
515410000040
Brand Name
GEM FLOW COUPLER External Lead
Version/Model Number
GEM1003EXT-FC
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
Yes
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
K093310,K093310
Product Code
DPW
Product Code Name
FLOWMETER, BLOOD, CARDIOVASCULAR
Public Device Record Key
4ceae1f9-f213-44fc-be35-7b69dc902022
Public Version Date
October 11, 2022
Public Version Number
5
DI Record Publish Date
September 24, 2016
Package DI Number
10844735005186
Quantity per Package
4
Contains DI Package
00844735005189
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| 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 |