CU+ Controller

GUDID B271CUP0

Meditech International Inc

Red-light phototherapy unit, line-powered
Primary Device IDB271CUP0
NIH Device Record Key1f4f8335-3b12-4a6c-a99c-6b44e4c9b7d7
Commercial Distribution StatusIn Commercial Distribution
Brand NameCU+ Controller
Version Model NumberCU+
Company DUNS255079485
Company NameMeditech International 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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB271CUP0 [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 Number3
Public Version Date2018-07-06
Device Publish Date2016-08-09

Devices Manufactured by Meditech International Inc

B271MCUI0 - MiniPort Main Controller Unit2023-10-10
B271ART1800 - ART1802023-09-26
B271CUPA0 - Arthritis Controller Unit2023-09-26
B271CU0 - CU Controller2018-07-06
B271CUP0 - CU+ Controller2018-07-06
B271CUP0 - CU+ Controller2018-07-06
B271DUO1800 - DUO+ 180 Treatment Head2018-07-06
B271DUO2400 - DUO+ 240 Treatment Head2018-07-06
B271LDI2000 - LD-I 200 Treatment Head2018-07-06

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