FEP001

GUDID 00857398006509

MULTI BIOSENSORS, INC.

Electrocardiographic electrode, single-use
Primary Device ID00857398006509
NIH Device Record Key75dabfe1-75bf-40cb-8b3a-40699780bbaf
Commercial Distribution StatusIn Commercial Distribution
Brand NameFEP001
Version Model NumberDisposable ECG-EMG electrode
Company DUNS154714232
Company NameMULTI BIOSENSORS, INC.
Device Count4
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone915-581-9684
Emailharold@multibiosensors.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100857398006493 [Unit of Use]
GS100857398006509 [Package]
Contains: 10857398006490
Package: [5 Units]
In Commercial Distribution
GS110857398006490 [Primary]

FDA Product Code

DRXElectrode, Electrocardiograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-10-25
Device Publish Date2019-10-17

Devices Manufactured by MULTI BIOSENSORS, INC.

00857398006509 - FEP0012019-10-25
00857398006509 - FEP0012019-10-25
00857398006158 - 2DT22018-06-18
00857398006363 - NET32018-05-17
20857398006244 - DE-3012018-03-29
00857398006455 - 46302018-03-29
00857398006479 - GS272018-03-29
00857398006264 - 3ST3-P2018-03-29
00857398006387 - 3PT3-62018-03-29

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