FDA.reportPublic FDA data

Munchkin

Primary DI
00735282383236
Brand
Munchkin
Company
MUNCHKIN, INC.
Model
MKFE0924 Rev 1
Catalog number
38323
Device description
Munchkin Flow Nipple Shield Starter Kit - 20mm
Published
2024-06-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HFSShield, Nipple

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HFSShield, NippleGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10735282383233PackageGS16In Commercial Distribution
00735282383236PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1073528238323310735282383233
00735282383236007352823832367352823832360735282383236

GMDN Terms#

Term, Definition table
TermDefinition
Nipple shielding teat, reusableA device in the form of a flexible dome with milk-flow holes designed to be worn on a nipple by a nursing mother to facilitate breast feeding when an infant has latch-on problems (i.e., aberrant suckling technique), is premature, ill, or small (suction inside the device holds the nipple in an extended position), or when the mother has flat or inverted nipples (it provides sensation deep in the mouth that stimulates the baby). It is typically made of preformed silicone materials that additionally provide nipple protection. This is a reusable device.

Sterilization Methods#

Method table
Method
Liquid Chemical

Contacts#

Phone, Email table
PhoneEmail
818 293-5000Vartan.Chldrian@munchkin.com
818 293-5000nelson.ipapo@munchkin.com

Regulatory Flags#

DUNS number
787026855
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

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
00735282383243MunchkinMKFE0924 Rev 2383242024-06-25
00735282383984MunchkinMKFE0925 Rev 1383982024-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06978707520081ParuuLinhejiacheng (Shenzhen) E-commerce Co., Ltd.HFS2026-03-11
06978707520098ParuuLinhejiacheng (Shenzhen) E-commerce Co., Ltd.HFS2026-03-11
06978707520104ParuuLinhejiacheng (Shenzhen) E-commerce Co., Ltd.HFS2026-03-11
06978707520111ParuuLinhejiacheng (Shenzhen) E-commerce Co., Ltd.HFS2026-03-11
06978707520128ParuuLinhejiacheng (Shenzhen) E-commerce Co., Ltd.HFS2026-03-11
00735282286810MunchkinMUNCHKIN, INC.HFS2025-02-12
10735282286817MunchkinMUNCHKIN, INC.HFS2025-02-12
09420060202021Silicone Nipple Shields (2pcs)THINK GREEN LIMITEDHFS2024-12-17
09420060202069Breastfeeding Nipple Shield - Orthodontic Teat (Triangle Base)THINK GREEN LIMITEDHFS2024-12-17
09420060202076Breastfeeding Nipple Shield - Orthodontic Teat (Round Base)THINK GREEN LIMITEDHFS2024-12-17
09420060202083BreastFeeding Nipple Shield - Butterfly ShapeTHINK GREEN LIMITEDHFS2024-12-17
09420060202090Flexi Silicone Nipple ShieldsTHINK GREEN LIMITEDHFS2024-12-17
09420060202038Ultra-Thin Silicone Nipple Shields - LTHINK GREEN LIMITEDHFS2024-12-16
09420060202045Ultra-Thin Silicone Nipple Shields - MTHINK GREEN LIMITEDHFS2024-12-16
09420060202052 Breastfeeding Nipple Shield - Round BaseTHINK GREEN LIMITEDHFS2024-12-16
09420060202014Silicone Nipple Shields (2pcs)THINK GREEN LIMITEDHFS2024-12-12
00735282281310MunchkinMUNCHKIN, INC.HFS2024-11-14
00735282281327MunchkinMUNCHKIN, INC.HFS2024-11-14
00735282281334MunchkinMUNCHKIN, INC.HFS2024-11-14
00735282281358MunchkinMUNCHKIN, INC.HFS2024-11-14
10735282281317MunchkinMUNCHKIN, INC.HFS2024-11-14
10735282281324MunchkinMUNCHKIN, INC.HFS2024-11-14
10735282281331MunchkinMUNCHKIN, INC.HFS2024-11-14
10735282281355MunchkinMUNCHKIN, INC.HFS2024-11-14
00735282383243MunchkinMUNCHKIN, INC.HFS2024-06-25
00735282383984MunchkinMUNCHKIN, INC.HFS2024-06-25
00735282383991MunchkinMUNCHKIN, INC.HFS2024-06-25
10735282383233MunchkinMUNCHKIN, INC.HFS2024-06-25
10735282383240MunchkinMUNCHKIN, INC.HFS2024-06-25
10735282383981MunchkinMUNCHKIN, INC.HFS2024-06-25