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Gem Flow Now

FDA UDI

Class II (US FDA UDI)

by Synovis Micro Companies Alliance, Inc

Identity

Trade Name
GEM FLOW NOW FDA UDI
Generic Name
Electromagnetic blood flowmeter FDA UDI
Device Name
Doppler Blood Flow Monitoring Device FDA UDI
Model / Reference
520002040011 FDA UDI
Description
Doppler Blood Flow Monitoring Device FDA UDI

Identifiers

Catalog Number
GEM2770-FN FDA UDI
Primary DI / UDI-DI
00844735006377 FDA UDI
510(k) Number
K233394 FDA UDI
FDA Product Code
IYN FDA UDI
ITX FDA UDI
GMDN Term
Electromagnetic blood flowmeter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1550 FDA UDI
892.1570 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Electromagnetic blood flowmeter

Gem Flow Now by Synovis Micro Companies Alliance, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Synovis Micro Companies Alliance, Inc

Sources (1)

  • FDA UDI f85ad5f5-124d-46ad-8ddc-5d8a7379a220 38 fields · synced May 30, 2026