CRP Probe CRP-20H

GUDID 00894912002517

PW Cardiovascular Doppler probe, 20 MHz

KOVEN TECHNOLOGY, INC.

Invasive vascular ultrasound system probe
Primary Device ID00894912002517
NIH Device Record Key1f6ed94a-1e67-4345-bf74-6bca6b7beedf
Commercial Distribution StatusIn Commercial Distribution
Brand NameCRP Probe
Version Model NumberCRP-20H
Catalog NumberCRP-20H
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100894912002517 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAFMonitor, Ultrasonic, Nonfetal

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00894912002517]

Hydrogen Peroxide


[00894912002517]

Hydrogen Peroxide


[00894912002517]

Hydrogen Peroxide


[00894912002517]

Hydrogen Peroxide


[00894912002517]

Hydrogen Peroxide


[00894912002517]

Hydrogen Peroxide


[00894912002517]

Hydrogen Peroxide


[00894912002517]

Hydrogen Peroxide


[00894912002517]

Hydrogen Peroxide


[00894912002517]

Hydrogen Peroxide


[00894912002517]

Hydrogen Peroxide


[00894912002517]

Hydrogen Peroxide


[00894912002517]

Hydrogen Peroxide


[00894912002517]

Hydrogen Peroxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-04-07
Device Publish Date2016-06-22

On-Brand Devices [CRP Probe]

008949120025241.2mm tip PW cardiovascular Doppler probe, 20 MHz
00894912002517PW Cardiovascular Doppler probe, 20 MHz
00894912002500PW Cardiovascular Doppler probe, 10 MHz

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.