Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3000215556

FEI Number

3000215556

Entity Name

MUNCHKIN INC.

City/State/Country

VAN NUYS, CA, US

Establishment Address

7835 GLORIA AVE, VAN NUYS, CA 91406, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Munchkin Inc. (Owner Number: 10028219)

Owner / Operator Contact Address

7835 Gloria Avenue, Van Nuys, CA 91406, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Orajel Front Teeth Teether, Orajel Middle Teeth Teether, Orajel Back Teeth Teether, Orajel Massaging Teether Munchkin Inc TheraBurpee Hot/Cold Gel Pack Hot/Cold Breast Therapy Gel Pack Munchkin Silicone Nursing Shell Munchkin Silicone Breastmilk Collector Clear Nose Nasal Aspirator Warm Touch Lactation Massager HYPO3 Munchkin Daily Diaper Rash Spray - Sample HYPO3 Munchkin Daily Diaper Rash Spray HYPO3 Munchkin Eczema Spray Munchkin SIlicon Breast Pump

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KYW	Container, Liquid Medication, Graduated	General Hospital	Class 1	880.6430	2009-01-08
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2024-01-10
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2020-12-04
PWA	Breast Pump Accessory, Milk Expression Aid, Via Positive Pressure	Obstetrics/Gynecology	Class 1	884.5150	2024-07-18
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2016-05-03
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2022-07-27
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2022-01-17
HGY	Pump, Breast, Non-Powered	Obstetrics/Gynecology	Class 1	884.5150	2024-07-18

Official Correspondent

Vartan Chldrian

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Munchkin Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K010462	Avita Corporation	AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)	2001-04-11
K760421	Arbrook Mfg. Corp.	THERMOMETER, SURVALENT-ELECTRONIC	1976-08-23
K813409	Yellow Springs Instrument Co., Inc.	MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER	1981-12-18
K830039	Science Development Corp.	SDC RECTAL TEMP. PROBE PRODUCT #1020	1983-02-23
K842199	Sharp Electronics Corp.	ELEC. DIGITAL THERMOMETER MT-20 & 30	1984-07-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R

Similar Registrations

Registration Number	Establishment Name	Location
1000264713	GUPPY PLASTIC INDUSTRIES (PENANG) SDN BHD	Bukit Mertajam, Penang Pulau Pinang, MY
3040185149	PT FOOD PACKAGING JAYA	Indramayu Jawa Barat, ID
3015916830	PACKERMAN SDN. BHD.	Melaka, MY
3010692406	SHANGHAI GUANGSHENG INDUSTRIAL CO.,LTD.	Shanghai, CN
1423537	Cardinal Health 200, LLC	Waukegan, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3000215556. Last updated year: 2026. Please use registration number 3000215556 when referencing this establishment in official correspondence.