VDP-08A VDP-08A

GUDID 00894912002579

PW pencil style Doppler probe, 8 MHz

KOVEN TECHNOLOGY, INC.

Invasive vascular ultrasound system probe
Primary Device ID00894912002579
NIH Device Record Key3ddcfaf8-40c7-4927-a00d-b174d4e5a008
Commercial Distribution StatusIn Commercial Distribution
Brand NameVDP-08A
Version Model NumberVDP-08A
Catalog NumberVDP-08A
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

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
Phone314-542-2101
Emailinfo@koven.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100894912002579 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, Ultrasonic, Diagnostic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00894912002579]

Hydrogen Peroxide

[00894912002579]

Hydrogen Peroxide

[00894912002579]

Hydrogen Peroxide

[00894912002579]

Hydrogen Peroxide

[00894912002579]

Hydrogen Peroxide

[00894912002579]

Hydrogen Peroxide

[00894912002579]

Hydrogen Peroxide

[00894912002579]

Hydrogen Peroxide

[00894912002579]

Hydrogen Peroxide

[00894912002579]

Hydrogen Peroxide

[00894912002579]

Hydrogen Peroxide

[00894912002579]

Hydrogen Peroxide

[00894912002579]

Hydrogen Peroxide

[00894912002579]

Hydrogen Peroxide

[00894912002579]

Hydrogen Peroxide

[00894912002579]

Hydrogen Peroxide

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-04-07
Device Publish Date2016-06-29

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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