full back conductive vest- large KV1004823

GUDID 00857771003637

with (8) 2 x 3 electrodes

BIOMEDICAL LIFE SYSTEMS, INC.

Transcutaneous electrical stimulation electrode
Primary Device ID00857771003637
NIH Device Record Key89d3ca3c-66a7-444d-a9bd-282885318fd0
Commercial Distribution StatusIn Commercial Distribution
Brand Namefull back conductive vest- large
Version Model NumberKV1004823
Catalog NumberKV1004823
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

Length13 Inch
Length13 Inch
Length13 Inch
Height12 Inch
Width2.5 Inch
Length13 Inch
Height12 Inch
Width2.5 Inch
Length13 Inch
Height12 Inch
Width2.5 Inch
Length13 Inch
Height12 Inch
Width2.5 Inch
Length13 Inch
Height12 Inch
Width2.5 Inch
Length13 Inch
Height12 Inch
Width2.5 Inch
Length13 Inch
Height12 Inch
Width2.5 Inch
Length13 Inch
Height12 Inch
Width2.5 Inch
Length13 Inch
Height12 Inch
Width2.5 Inch
Length13 Inch
Height12 Inch
Width2.5 Inch
Length13 Inch
Height12 Inch
Width2.5 Inch
Length13 Inch
Height12 Inch
Width2.5 Inch
Length13 Inch
Height12 Inch
Width2.5 Inch
Length13 Inch
Height12 Inch
Width2.5 Inch
Length13 Inch
Height12 Inch
Width2.5 Inch
Length13 Inch
Height12 Inch
Width2.5 Inch
Length13 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100857771003637 [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

Devices Manufactured by BIOMEDICAL LIFE SYSTEMS, INC.

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20857771003594 - 2" x 2" pigtail electrode2024-09-03 1 Carton - 5 Inner Boxes / Carton, 10 Pouches / Inner Box, 10 Packs / Pouch. 4 Each / Pack
10857771003597 - 2" x 2" pigtail electrode - Inner Box 2024-08-27 1 Inner Box - 10 Pouches / Inner Box, 10 Packs / Pouch. 4 Each / Pack
00850706007304 - 2" x 2" Rectangle Electrodes2024-08-15 BioStim 2" x 2" Rectangle Electrodes - 10 pouches of 4 each
00857771003422 - Impulse TENS D52024-08-15
00857771003354 - BioKnit Conductive Shoulder Support Garment - Kit2022-08-03 Conductive Shoulder Garment with 4- 2x3 Electrodes
00857771003385 - BioKnit Back Brace 7" Conductive Garment - Kit2022-08-03 Back Brace 7" Conductive Garment with 4- 2x3 Electrodes
00857771003347 - BioKnit conductive sock - universal fit2021-05-13 BioKnit conductive sock - universal fit

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