FDA.reportPublic FDA data

HYPO3 Skin Cleanser Daily Diaper Rash Spray

Primary DI
10735282400992
Brand
HYPO3 Skin Cleanser Daily Diaper Rash Spray
Company
MUNCHKIN, INC.
Model
40099
Device description
Skin Cleanser for Diaper Rash Removes germs from skin
Published
2022-08-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160095000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160095000Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science Antimicrobial Wound & Skin Cleanser 8oz, Simple Science Antimicrobial Wound & Skin Cleanser 16oz, Simple Science Antimicrobial Wound & Skin Cleanser 23ozSimple Science, LLC2016-06-10FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00735282213717PackageGS12In Commercial Distribution
10735282213714PackageGS112In Commercial Distribution
10735282400992PackageGS124In Commercial Distribution
00735282400995PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00735282213717007352822137177352822137170735282213717
1073528221371410735282213714
1073528240099210735282400992
00735282400995007352824009957352824009950735282400995

GMDN Terms#

Term, Definition table
TermDefinition
Antimicrobial wound irrigation solution, non-sterileA non-sterile solution that includes an antimicrobial agent (e.g., sodium hypochlorite) intended to be used to irrigate and clean acute or chronic wounds, including first or second degree burns, to aid in autolytic debridment and to moisten a wound dressing(s), and to support natural healing. It is intended to be used in the home or healthcare facility. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume3.4Fluid Ounce

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
787026855
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10735282287845MunchkinMKCA0999 Rev 12026-03-18
00735282213182TheraBurpee Reusable Hot & Cold Gel Packs - 2pk213182021-10-01
00735282286810MunchkinMKFE0964 Rev 1286812025-02-12
10735282286817MunchkinMKFE0964 Rev 1286812025-02-12
00735282281310MunchkinMKFE0951 Rev 2281312024-11-14
00735282281327MunchkinMKFE0952 Rev 2281322024-11-14
00735282281334MunchkinMKFE0951 Rev 1281332024-11-14
00735282281358MunchkinMKFE0952 Rev 1281352024-11-14
10735282281317MunchkinMKFE0951 Rev 2281312024-11-14
10735282281324MunchkinMKFE0952 Rev 2281322024-11-14
10735282281331MunchkinMKFE0951 Rev 1281332024-11-14
10735282281355MunchkinMKFE0952 Rev 1281352024-11-14
00735282381843MunchkinMKFE0927 Rev 1381842024-08-01
00735282381850MunchkinMKFE0923 Rev 1381852024-08-01
00735282383946MunchkinMKFE0927 Rev 1383942024-08-01
10735282381840MunchkinMKFE0927 Rev 1381842024-08-01
10735282381857MunchkinMKFE0923 Rev 1381852024-08-01
10735282383943MunchkinMKFE0927 Rev 1383942024-08-01
00735282383236MunchkinMKFE0924 Rev 1383232024-06-25
00735282383243MunchkinMKFE0924 Rev 2383242024-06-25

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10197344169450MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-17
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