DEVICE: GEM FLOW NOW (00844735006377)
Device Identifier (DI) Information
GEM FLOW NOW
520002040011
In Commercial Distribution
GEM2770-FN
SYNOVIS MICRO COMPANIES ALLIANCE, INC
520002040011
In Commercial Distribution
GEM2770-FN
SYNOVIS MICRO COMPANIES ALLIANCE, INC
Doppler Blood Flow Monitoring Device
Device Characteristics
MR Conditional | |
No | |
Yes | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
10431 | Electromagnetic blood flowmeter |
A device using electromagnetic (EM) technology to provide a method of confirming and measuring the velocity of blood flow in vessels after coronary artery bypass, organ transplant, and other vascular reconstructive surgery. It uses an invasive technique that is performed with either a catheter inserted into a vessel or with a probe that surrounds a surgically exposed vessel without penetrating the vessel wall. Also known as an EM flowmeter.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
IYN | System, imaging, pulsed doppler, ultrasonic |
ITX | Transducer, ultrasonic, diagnostic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K233394 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 15 and 25 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Vessel Diameter: 2-4 Millimeter |
Device Record Status
f85ad5f5-124d-46ad-8ddc-5d8a7379a220
November 29, 2024
1
November 21, 2024
November 29, 2024
1
November 21, 2024
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)510-3318
smca_information@baxter.com
smca_information@baxter.com