02-4301

GUDID 00857398006448

MULTI BIOSENSORS, INC.

Electrocardiographic electrode, single-use
Primary Device ID00857398006448
NIH Device Record Keyb2e760c8-51fe-4a26-8b20-cd87a1b6f275
Commercial Distribution StatusIn Commercial Distribution
Brand Name02-4301
Version Model NumberDisposable ECG-EMG electrode
Company DUNS154714232
Company NameMULTI BIOSENSORS, INC.
Device Count102
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
GS100857398006035 [Unit of Use]
GS100857398006448 [Primary]

FDA Product Code

DRXElectrode, Electrocardiograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-02-28

Devices Manufactured by MULTI BIOSENSORS, INC.

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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