ES101EX ES101EX-2

GUDID 00894912002074

Fetal Echosounder Doppler.

KOVEN TECHNOLOGY, INC.

Foetal Doppler system
Primary Device ID00894912002074
NIH Device Record Keye3beb1be-3682-40a4-ba62-3caae10c9276
Commercial Distribution Discontinuation2021-02-03
Commercial Distribution StatusNot in Commercial Distribution
Brand NameES101EX
Version Model NumberES101EX-2
Catalog NumberES101EX-2
Company DUNS069261402
Company NameKOVEN TECHNOLOGY, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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

Customer Support Contacts

Phone314-542-2101
Emailinfo@koven.com
Phone314-542-2101
Emailinfo@koven.com
Phone314-542-2101
Emailinfo@koven.com
Phone314-542-2101
Emailinfo@koven.com
Phone314-542-2101
Emailinfo@koven.com
Phone314-542-2101
Emailinfo@koven.com
Phone314-542-2101
Emailinfo@koven.com
Phone314-542-2101
Emailinfo@koven.com
Phone314-542-2101
Emailinfo@koven.com
Phone314-542-2101
Emailinfo@koven.com
Phone314-542-2101
Emailinfo@koven.com
Phone314-542-2101
Emailinfo@koven.com
Phone314-542-2101
Emailinfo@koven.com
Phone314-542-2101
Emailinfo@koven.com
Phone314-542-2101
Emailinfo@koven.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100894912002074 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNGMonitor, Ultrasonic, Fetal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-02-04
Device Publish Date2016-02-24

Devices Manufactured by KOVEN TECHNOLOGY, INC.

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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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