Compact FM

GUDID 00815871020220

Avante

Foetal cardiac monitor Foetal cardiac monitor Foetal cardiac monitor
Primary Device ID00815871020220
NIH Device Record Key0f77019c-dcac-4faf-a6a3-add1206826fa
Commercial Distribution StatusIn Commercial Distribution
Brand NameCompact FM
Version Model Number60130TD
Company DUNS178440426
Company NameAvante
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone502-244-4444
Emaildevicehelp@dremed.com
Phone502-244-4444
Emaildevicehelp@dremed.com
Phone502-244-4444
Emaildevicehelp@dremed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100815871020220 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HGMSystem, Monitoring, Perinatal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-03-02
Device Publish Date2016-09-23

On-Brand Devices [Compact FM]

0081587102022060130TD
0081587102021360130T
0081587102020660130EXP
0081587102019060130

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