BioMed Revived II BRVE2

GUDID 00857771003996

BioMed Revivied II

BIOMEDICAL LIFE SYSTEMS, INC.

Analgesic transcutaneous electrical nerve stimulation system
Primary Device ID00857771003996
NIH Device Record Keyd3dd6324-f140-404c-a6da-4b2794f945f8
Commercial Distribution StatusIn Commercial Distribution
Brand NameBioMed Revived II
Version Model NumberBRVE2
Catalog NumberBRVE2
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 Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Countertrue

Customer Support Contacts

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
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
GS100857771003996 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NGXStimulator, Muscle, Powered, For Muscle Conditioning

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-10-23
Device Publish Date2019-09-20

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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