Pulse H2Oh!

GUDID 00867003000204

Water based personal lubricant

TOASTER LABS, INC.

Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant
Primary Device ID00867003000204
NIH Device Record Key8d738f06-9317-4f2f-a460-a5f5b7b8da65
Commercial Distribution StatusIn Commercial Distribution
Brand NamePulse H2Oh!
Version Model Number1
Company DUNS079882181
Company NameTOASTER LABS, 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 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
GS100867003000204 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NUCLubricant, Personal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2018-08-14
Device Publish Date2017-01-03

Devices Manufactured by TOASTER LABS, INC.

00867003000204 - Pulse H2Oh!2018-08-14Water based personal lubricant
00867003000204 - Pulse H2Oh!2018-08-14 Water based personal lubricant
00867003000211 - Pulse Aloe-ahh2018-08-14 Silicone based personal lubricant

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