BioKnit Conductive Garment KB0961

GUDID 00857771003552

qty 2 ea/pk with 2 x 3 electrodes

BIOMEDICAL LIFE SYSTEMS, INC.

Transcutaneous electrical stimulation electrode
Primary Device ID00857771003552
NIH Device Record Key40c947e1-45ce-46a4-925b-5b2ec47ea324
Commercial Distribution StatusIn Commercial Distribution
Brand NameBioKnit Conductive Garment
Version Model NumberKB0961 univ. cervical
Catalog NumberKB0961
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone7607275600
Emailinformation@bmls.com
Phone7607275600
Emailinformation@bmls.com
Phone7607275600
Emailinformation@bmls.com
Phone7607275600
Emailinformation@bmls.com
Phone7607275600
Emailinformation@bmls.com
Phone7607275600
Emailinformation@bmls.com
Phone7607275600
Emailinformation@bmls.com
Phone7607275600
Emailinformation@bmls.com
Phone7607275600
Emailinformation@bmls.com
Phone7607275600
Emailinformation@bmls.com
Phone7607275600
Emailinformation@bmls.com
Phone7607275600
Emailinformation@bmls.com
Phone7607275600
Emailinformation@bmls.com
Phone7607275600
Emailinformation@bmls.com
Phone7607275600
Emailinformation@bmls.com
Phone7607275600
Emailinformation@bmls.com
Phone7607275600
Emailinformation@bmls.com

Device Dimensions

Width1 Inch
Width1 Inch
Width1 Inch
Height8 Inch
Length11 Inch
Width1 Inch
Height8 Inch
Length11 Inch
Width1 Inch
Height8 Inch
Length11 Inch
Width1 Inch
Height8 Inch
Length11 Inch
Width1 Inch
Height8 Inch
Length11 Inch
Width1 Inch
Height8 Inch
Length11 Inch
Width1 Inch
Height8 Inch
Length11 Inch
Width1 Inch
Height8 Inch
Length11 Inch
Width1 Inch
Height8 Inch
Length11 Inch
Width1 Inch
Height8 Inch
Length11 Inch
Width1 Inch
Height8 Inch
Length11 Inch
Width1 Inch
Height8 Inch
Length11 Inch
Width1 Inch
Height8 Inch
Length11 Inch
Width1 Inch
Height8 Inch
Length11 Inch
Width1 Inch
Height8 Inch
Length11 Inch
Width1 Inch
Height8 Inch
Length11 Inch
Width1 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100857771003552 [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 Date2016-09-23

On-Brand Devices [BioKnit Conductive Garment]

00857771003552qty 2 ea/pk with 2 x 3 electrodes
00857771003545sport shoulder univ with 4- 2x3 electrodes

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