DUOFLEX+ 120 Treatment Head

GUDID B271LSB32700

DUOFLEX+ 120 Treatment Head

Meditech International Inc

Red-light phototherapy unit, line-powered
Primary Device IDB271LSB32700
NIH Device Record Key2ec2149c-7279-4d10-9aa6-1611ee525b11
Commercial Distribution StatusIn Commercial Distribution
Brand NameDUOFLEX+ 120 Treatment Head
Version Model NumberLS-B 3270
Company DUNS255079485
Company NameMeditech International Inc
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB271LSB32700 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ILYLamp, Infrared, Therapeutic Heating

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2018-02-01

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B271DUO1800 - DUO+ 180 Treatment Head2018-07-06
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B271LDI2000 - LD-I 200 Treatment Head2018-07-06

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