TRIA II Doppler

GUDID 00888937001280

With 8.0 MHz Vascular Probe

Coopersurgical, Inc.

Noninvasive vascular ultrasound system, battery-powered
Primary Device ID00888937001280
NIH Device Record Key511c085c-ec76-499b-95e4-186107680d59
Commercial Distribution StatusIn Commercial Distribution
Brand NameTRIA II Doppler
Version Model NumberT337
Company DUNS801895244
Company NameCoopersurgical, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100888937001280 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HEPMonitor, Blood-Flow, Ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-03-31

On-Brand Devices [TRIA II Doppler]

00888937001327With 2.0 MHz Obstetrical Probe
00888937001310With 8.0 MHz Sterilizable Vascular Probe
00888937001280With 8.0 MHz Vascular Probe
00888937001259With 5.0 MHz Vascular Probe
00888937001235With 3.0 MHz Fetal Probe

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