DEVICE: GEM FLOW NOW (00844735006377)

Device Identifier (DI) Information

GEM FLOW NOW
520002040011
In Commercial Distribution
GEM2770-FN
SYNOVIS MICRO COMPANIES ALLIANCE, INC
00844735006377
GS1

1
031284586 *Terms of Use
Doppler Blood Flow Monitoring Device
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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
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FDA Product Code

[?]
Product Code Product Code Name
IYN System, imaging, pulsed doppler, ultrasonic
ITX Transducer, ultrasonic, diagnostic
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K233394 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 15 and 25 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Vessel Diameter: 2-4 Millimeter
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Device Record Status

f85ad5f5-124d-46ad-8ddc-5d8a7379a220
November 29, 2024
1
November 21, 2024
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+1(800)510-3318
smca_information@baxter.com
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