BT8M05S8AXT BT8M05S8AXT

GUDID 00894912002937

8 MHz CW Doppler probe for the Smartdop XT.

KOVEN TECHNOLOGY, INC.

Noninvasive vascular ultrasound system probe
Primary Device ID00894912002937
NIH Device Record Keydaa6bfde-adc1-426a-9479-69e39eb55938
Commercial Distribution Discontinuation2018-01-02
Commercial Distribution StatusNot in Commercial Distribution
Brand NameBT8M05S8AXT
Version Model NumberBT8M05S8AXT
Catalog NumberBT8M05S8AXT
Company DUNS069261402
Company NameKOVEN TECHNOLOGY, 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
GS100894912002937 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JOPTransducer, Ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-11-03
Device Publish Date2016-06-17

Devices Manufactured by KOVEN TECHNOLOGY, INC.

00894912002043 - BiDop 32023-11-03 Bidirectional Doppler with waveform display.
00894912002197 - PG-212023-11-03 PPG probe module.
00894912002203 - PGV-202023-11-03 PPG and Pulse Volume combo module for Smartdops.
00894912002296 - BF8M15S8A2023-11-03 8 MHz flat clinic CW Doppler probe.
00894912002302 - BT10M5S8A2023-11-03 10 MHz straight cable clinic CW Doppler probe.
00894912002319 - BT10M5S8C2023-11-03 10 MHz curly cable clinic CW Doppler probe.
00894912002333 - BT5M05S8A2023-11-03 5 MHz straight cable clinic CW Doppler probe.
00894912002340 - BT5M05S8C2023-11-03 5 MHz curly cable clinic CW Doppler probe.

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