Munchkin

Basic Information

• Brand Name: Munchkin
• Primary DI: 00735282383984
• Version / Model: MKFE0925 Rev 1
• Catalog Number: 38398
• Company Name: MUNCHKIN, INC.
• Labeler DUNS: 787026855
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-06-25
• Public Version: 1
• Public Version Date: 2024-07-03
• Public Version Status: New
• Public Device Record Key: d5f60a0e-0da6-4b1b-ad7e-fc72a0591256

Device Description

Munchkin Flow Nipple Shield Replacement Kit - 20 mm

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Liquid Chemical

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HFS	Shield, Nipple	General Hospital	880.5630	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35337	Nipple shielding teat, reusable	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10735282383981	GS1	case	6	In Commercial Distribution
Primary	00735282383984	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]