NPure System

GUDID 00850017374096

NEAUVIA NORTH AMERICA, INC.

Room dehumidifier Room dehumidifier Room dehumidifier Room dehumidifier Room dehumidifier Room dehumidifier Room dehumidifier Room dehumidifier Room dehumidifier Room dehumidifier Room dehumidifier Room dehumidifier Room dehumidifier Room dehumidifier Room dehumidifier Room dehumidifier
Primary Device ID00850017374096
NIH Device Record Keyf3fb4947-da2f-4ca9-b3b8-fdbb5f26bf14
Commercial Distribution StatusIn Commercial Distribution
Brand NameNPure System
Version Model Number100-1500
Company DUNS117030786
Company NameNEAUVIA NORTH AMERICA, 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 Datefalse
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
GS100850017374096 [Primary]

FDA Product Code

LRJDisinfectant, Medical Devices

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-04
Device Publish Date2021-09-24

Devices Manufactured by NEAUVIA NORTH AMERICA, INC.

00850017374188 - LaserMe2023-08-23 The LaserMe is intended for use in dermatological procedures requiring coagulation of soft tissue and skin resurfacing procedure
00850017374201 - EpilMe System2022-10-11 Laser EpilME with EpilME applictor is indicated for use in surgical and aesthetic applications in the medical specialties of gen
00850017374218 - EpilMe Applicator2022-10-11 Handpiece applicator for EpilMe System
00850017374126 - Sectum System2021-10-05
00850017374133 - Sectum Precise (Face) Applicator2021-10-05
00850017374140 - Sectum Body Applicator2021-10-05
00850017374157 - Sectum Foot Switch2021-10-05 Foot switch for the Sectum System
00850017374164 - Sectum Cable Body Applicator2021-10-05

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