Duns Number:031284586
Device Description: An insulated electrical cord (one piece) designed to connect the Flow COUPLER Monitor to a An insulated electrical cord (one piece) designed to connect the Flow COUPLER Monitor to a mains electricity supply socket. It has four adapters to accommodate voltage specific to the EU, UK, US, and Australia.
Catalog Number
515600001011
Brand Name
GEM FLOW COUPLER AC POWER SUPPLY KIT, US
Version/Model Number
GEM1020PS-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
09fefaa1-c016-44d6-903b-9ca34540886d
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 |