Remedium International LLC

GUDID 00860456000920

REMEDIUM INTERNATIONAL LLC

Nebulizing system, non-heated
Primary Device ID00860456000920
NIH Device Record Key120e345e-3ff5-49bd-8e40-6f0dbaa48ddc
Commercial Distribution StatusIn Commercial Distribution
Brand NameRemedium International LLC
Version Model NumberJLN-2305 BS
Company DUNS081019576
Company NameREMEDIUM INTERNATIONAL LLC
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 Batchtrue
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
GS100860456000920 [Primary]

FDA Product Code

CAFNebulizer (Direct Patient Interface)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-04-30
Device Publish Date2018-03-29

On-Brand Devices [Remedium International LLC]

00860456000937JLN-2300 AS
00860456000920JLN-2305 BS
00860456000913JLN-2320 AS

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