T2M20S8C T2M20S8C

GUDID 00894912002432

2 MHz CW Doppler probe.

KOVEN TECHNOLOGY, INC.

Foetal Doppler system probe
Primary Device ID00894912002432
NIH Device Record Keya6e5e5d2-32fb-498e-92d9-4ae8f934b0c2
Commercial Distribution StatusIn Commercial Distribution
Brand NameT2M20S8C
Version Model NumberT2M20S8C
Catalog NumberT2M20S8C
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100894912002432 [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 Date2022-11-28
Device Publish Date2016-03-10

Devices Manufactured by KOVEN TECHNOLOGY, INC.

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