DE-301

GUDID 20857398006244

MULTI BIOSENSORS, INC.

Electrocardiographic electrode, single-use
Primary Device ID20857398006244
NIH Device Record Key4e6f33f8-598a-48e9-9c6b-736bd8f01676
Commercial Distribution StatusIn Commercial Distribution
Brand NameDE-301
Version Model NumberDisposable ECG-EMG electrode
Company DUNS154714232
Company NameMULTI BIOSENSORS, INC.
Device Count6
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
Phone915-581-9684
Emailharold@multibiosensors.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100857398006240 [Unit of Use]
GS100857398006431 [Package]
Package: Bag [25 Units]
In Commercial Distribution
GS120857398006244 [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 Date2017-02-02

Devices Manufactured by MULTI BIOSENSORS, INC.

00857398006509 - FEP0012019-10-25
00857398006158 - 2DT22018-06-18
00857398006363 - NET32018-05-17
20857398006244 - DE-3012018-03-29
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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