Univ Full Back w (8) 2x3 electrodes KV1016823

GUDID 00850706007038

BIOMEDICAL LIFE SYSTEMS, INC.

Transcutaneous electrical stimulation electrode
Primary Device ID00850706007038
NIH Device Record Keyc083b941-02bb-49d5-bf30-d33c99e98fc8
Commercial Distribution StatusIn Commercial Distribution
Brand NameUniv Full Back w (8) 2x3 electrodes
Version Model NumberKV1016823
Catalog NumberKV1016823
Company DUNS116956807
Company NameBIOMEDICAL LIFE SYSTEMS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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
GS100850706007038 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXYElectrode, Cutaneous

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-06-28
Device Publish Date2016-12-22

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