Ice Heart

GUDID 00735282447150

Cool gel that soothes gums Ridges to massage sore gums Easy-to-grasp heart shape

MUNCHKIN, INC.

Teething device, fluid-filled
Primary Device ID00735282447150
NIH Device Record Key6f8d3347-050b-45b2-9e83-3b9aecccc28a
Commercial Distribution StatusIn Commercial Distribution
Brand NameIce Heart
Version Model Number44715
Company DUNS787026855
Company NameMUNCHKIN, INC.
Device Count1
DM Exempttrue
Pre-market Exempttrue
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-344-2229
Emailcserve@munchkin.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100735282447150 [Primary]

FDA Product Code

KKORing, Teething, Fluid-Filled

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-11
Device Publish Date2019-02-14

Devices Manufactured by MUNCHKIN, INC.

10735282281317 - Munchkin2024-11-22 Munchkin Flow Nipple Shield Replacement Kit - 16mm
10735282281324 - Munchkin2024-11-22 Munchkin Flow Nipple Shield Replacement Kit - 28mm
10735282281331 - Munchkin2024-11-22 Munchkin Flow Nipple Shield Starter Kit - 16mm
10735282281355 - Munchkin2024-11-22 Munchkin Flow Nipple Shield Starter Kit - 28mm
10735282381840 - Munchkin2024-08-09 1pk Milk Collection Cup
10735282381857 - Munchkin2024-08-09 Munchkin Silicone Breast Pump
10735282383943 - Munchkin2024-08-09 2pk Milk Collection Cup
10735282383233 - Munchkin2024-07-03 Munchkin Flow Nipple Shield Starter Kit - 20mm

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.