We-Vibe Lube

GUDID 40827160111463

Water-based Personal Lubricant

Pjur Group Luxembourg SA

Sexual lubricant
Primary Device ID40827160111463
NIH Device Record Key01d44227-e68f-4bc4-8b46-0a3ddfc507ec
Commercial Distribution StatusIn Commercial Distribution
Brand NameWe-Vibe Lube
Version Model NumberWe-Vibe Lube 2 ml - USA
Company DUNS400744553
Company NamePjur Group Luxembourg SA
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100827160111465 [Primary]
GS110827160111462 [Package]
Contains: 00827160111465
Package: pack [50 Units]
In Commercial Distribution
GS140827160111463 [Package]
Contains: 10827160111462
Package: case [20 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NUCLubricant, Personal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-02-04
Device Publish Date2019-01-03

On-Brand Devices [We-Vibe Lube]

40827160112712Water-based Personal Lubricant
40827160111463Water-based Personal Lubricant
40827160111456Water-based Personal Lubricant

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