HYPO3 Skin Cleanser Daily Diaper Rash Spray

GUDID 10735282400992

Skin Cleanser for Diaper Rash Removes germs from skin

MUNCHKIN, INC.

Antimicrobial wound irrigation solution, non-sterile
Primary Device ID10735282400992
NIH Device Record Key64cfd791-bc02-4ab8-8bf6-91872a76864b
Commercial Distribution StatusIn Commercial Distribution
Brand NameHYPO3 Skin Cleanser Daily Diaper Rash Spray
Version Model Number40099
Company DUNS787026855
Company NameMUNCHKIN, 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 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 Dimensions

Total Volume3.4 Fluid Ounce
Total Volume3.4 Fluid Ounce
Total Volume3.4 Fluid Ounce
Total Volume3.4 Fluid Ounce
Total Volume3.4 Fluid Ounce
Total Volume3.4 Fluid Ounce
Total Volume3.4 Fluid Ounce
Total Volume3.4 Fluid Ounce
Total Volume3.4 Fluid Ounce
Total Volume3.4 Fluid Ounce
Total Volume3.4 Fluid Ounce
Total Volume3.4 Fluid Ounce
Total Volume3.4 Fluid Ounce
Total Volume3.4 Fluid Ounce
Total Volume3.4 Fluid Ounce
Total Volume3.4 Fluid Ounce
Total Volume3.4 Fluid Ounce
Total Volume3.4 Fluid Ounce
Total Volume3.4 Fluid Ounce
Total Volume3.4 Fluid Ounce
Total Volume3.4 Fluid Ounce
Total Volume3.4 Fluid Ounce
Total Volume3.4 Fluid Ounce
Total Volume3.4 Fluid Ounce
Total Volume3.4 Fluid Ounce
Total Volume3.4 Fluid Ounce
Total Volume3.4 Fluid Ounce

Device Identifiers

Device Issuing AgencyDevice ID
GS100735282213717 [Package]
Contains: 00735282400995
Package: Unit [2 Units]
In Commercial Distribution
GS100735282400995 [Primary]
GS110735282213714 [Package]
Contains: 00735282213717
Package: Case [12 Units]
In Commercial Distribution
GS110735282400992 [Package]
Contains: 00735282400995
Package: Case [24 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FRODressing, Wound, Drug

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-02
Device Publish Date2022-08-25

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