Conductive garment electrode glove med. GAR111

GUDID 00850706007014

BIOMEDICAL LIFE SYSTEMS, INC.

Transcutaneous electrical stimulation electrode
Primary Device ID00850706007014
NIH Device Record Key7a29177d-11d0-4f86-996b-e01aab540a0a
Commercial Distribution StatusIn Commercial Distribution
Brand NameConductive garment electrode glove med.
Version Model NumberGAR111
Catalog NumberGAR111
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 Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone7607275600
Emailinformation@bmls.com
Phone7607275600
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Phone7607275600
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Phone7607275600
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Phone7607275600
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Phone7607275600
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Phone7607275600
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Phone7607275600
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Phone7607275600
Emailinformation@bmls.com
Phone7607275600
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Phone7605790801
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Phone7605790801
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Phone7605790801
Emailinformation@bmls.com
Phone7605790801
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Phone7605790801
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Phone7605790801
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Phone7605790801
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Phone7605790801
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Phone7605790801
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Phone7605790801
Emailinformation@bmls.com
Phone7605790801
Emailinformation@bmls.com
Phone7605790801
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Phone7605790801
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Phone7605790801
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Phone7605790801
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Phone7605790801
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Phone7605790801
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Phone7605790801
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Phone7605790801
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Phone7605790801
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Phone7605790801
Emailinformation@bmls.com
Phone7605790801
Emailinformation@bmls.com
Phone7605790801
Emailinformation@bmls.com
Phone7605790801
Emailinformation@bmls.com
Phone7605790801
Emailinformation@bmls.com
Phone7605790801
Emailinformation@bmls.com
Phone7605790801
Emailinformation@bmls.com
Phone7605790801
Emailinformation@bmls.com
Phone7605790801
Emailinformation@bmls.com
Phone7605790801
Emailinformation@bmls.com
Phone7605790801
Emailinformation@bmls.com
Phone7605790801
Emailinformation@bmls.com
Phone7605790801
Emailinformation@bmls.com
Phone7605790801
Emailinformation@bmls.com
Phone7605790801
Emailinformation@bmls.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850706007014 [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 Number6
Public Version Date2020-04-01
Device Publish Date2016-09-23

Devices Manufactured by BIOMEDICAL LIFE SYSTEMS, INC.

00857771003590 - 2" x 2" pigtail electrode 2024-09-03 1 Pouch - 10 Packs / Pouch. 4 Each / PaCK.
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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