Foundation Consumer Healthcare

FDA Device Registration & Listing · Pittsburgh, PA, US · Registration 3010200299

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3010200299
FEI Number
3010200299
Entity Name
Foundation Consumer Healthcare
City/State/Country
Pittsburgh, PA, US
Establishment Address
106 Isabella Street, Suite 602, Pittsburgh, PA 15215, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Foundation Consumer Healthcare LLC (Owner Number: 10053684)
Owner / Operator Contact Address
106 Isabella Street, Suite 602, Pittsburgh, PA 15215, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Breathe Right Sparkling Saline Nasal Rinse Spray

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KCO Nasal Spray, Ent Delivery Ear, Nose, Throat Class 1 874.5220 2024-07-29
LWF Dilator, Nasal Ear, Nose, Throat Class 1 874.3900 2022-10-28

Official Correspondent

May Petracco

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Foundation Consumer Healthcare LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Similar Registrations

Registration Number Establishment Name Location
3033571062 MERZ PHARMACEUTICALS, LLC Raleigh, NC, US
1526711 ISOMEDIX OPERATIONS INC GROVEPORT, OH, US
3021011196 E-LINKCARE MEDITECH CO., LTD. Taizhou Zhejiang, CN
3012896103 SHENZHEN BALINDA TECHNOLOGY CO.,LTD Shenzhen Guangdong, CN
3016170587 TIANJIN HODAF TECHNOLOGY CO., LTD. TIANJIN, CN
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010200299. Last updated year: 2026. Please use registration number 3010200299 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.