FC1400

GUDID 18809276943603

SYSTEM, MONITORING, PERINATAL

Bionet CO,LTD

Foetal cardiac monitor Foetal cardiac monitor Foetal cardiac monitor Foetal cardiac monitor Foetal cardiac monitor Foetal cardiac monitor Foetal cardiac monitor Foetal cardiac monitor Foetal cardiac monitor Foetal cardiac monitor Foetal cardiac monitor Foetal cardiac monitor Foetal cardiac monitor Foetal cardiac monitor Foetal cardiac monitor
Primary Device ID18809276943603
NIH Device Record Key5cdc5581-ef3a-411e-8eeb-f70f36410e42
Commercial Distribution StatusIn Commercial Distribution
Brand NameFC1400
Version Model NumberFC1400
Company DUNS689708212
Company NameBionet CO,LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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

Device Identifiers

Device Issuing AgencyDevice ID
GS108809276943606 [Primary]
GS118809276943603 [Package]
Contains: 08809276943606
Package: Box [4 Units]
In Commercial Distribution

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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-23
Device Publish Date2021-07-15

Devices Manufactured by Bionet CO,LTD

18809276940282 - CardioXP2021-07-23 ELECTROCARDIOGRAPH
18809276943535 - CardioCare20002021-07-23 System, ecg analysis
18809276943542 - CardioTouch30002021-07-23 System, ecg analysis
18809276943559 - Cardio72021-07-23 ELECTROCARDIOGRAPH
18809276943597 - FC7002021-07-23 SYSTEM, MONITORING, PERINATAL
18809276943603 - FC14002021-07-23SYSTEM, MONITORING, PERINATAL
18809276943603 - FC14002021-07-23 SYSTEM, MONITORING, PERINATAL
18809276943641 - BM3/BM3 Plus2021-07-23 MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)
18809276943726 - Spiro Handle2021-07-23 SPIROMETER, DIAGNOSTIC

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