T2M25N8A T2M25N8A

GUDID 00894912002463

2 MHz Fetal Doppler probe for the ES102EX fetal Doppler.

KOVEN TECHNOLOGY, INC.

Foetal Doppler system probe
Primary Device ID00894912002463
NIH Device Record Key6187c9e1-e3d2-4619-b6de-eec8e4e0e3ed
Commercial Distribution StatusIn Commercial Distribution
Brand NameT2M25N8A
Version Model NumberT2M25N8A
Catalog NumberT2M25N8A
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
GS100894912002463 [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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