LUMISCOPE

GUDID M368SW10002

Standard TENS Unit

GF HEALTH PRODUCTS, INC.

Analgesic transcutaneous electrical nerve stimulation system
Primary Device IDM368SW10002
NIH Device Record Keyb67907c0-bd56-4fb0-9658-5aaffdc615a4
Commercial Distribution StatusIn Commercial Distribution
Brand NameLUMISCOPE
Version Model NumberSW-1000
Company DUNS132016168
Company NameGF HEALTH PRODUCTS, 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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone770-368-4700
Emailcs@grahamfield.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM368SW10001 [Primary]
HIBCCM368SW10002 [Package]
Contains: M368SW10001
Package: [24 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZJStimulator, Nerve, Transcutaneous, For Pain Relief

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-10-23
Device Publish Date2016-08-31

On-Brand Devices [LUMISCOPE]

M36811372Advanced Upper Arm Blood Pressure Monitor
M368SW10002Standard TENS Unit
M368LUMITENS2Economy TENS Unit
M3682000T1Deluxe TENS Unit
M36811333Automatic Blood Pressure Monitor
M3682040061#NURSES STETH BLUE LOT#
M36867003Portable Ultrasonic Nebulizer
M36811431Automatic Wrist Blood Pressure Monitor

Trademark Results [LUMISCOPE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
LUMISCOPE
LUMISCOPE
76303432 2631187 Live/Registered
GF HEALTH PRODUCTS, INC.
2001-08-23
LUMISCOPE
LUMISCOPE
73443255 1360572 Dead/Cancelled
WOBBOT INTERNATIONAL LIMITED
1983-09-12

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