Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011390406

FEI Number

3011390406

Entity Name

FIREFLY MEDICAL, INC.

City/State/Country

Fort Collins, CO, US

Establishment Address

320 E Vine Dr Ste 315, Fort Collins, CO 80524, US

Establishment Type(s)

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

Owner / Operator

FIREFLY MEDICAL, INC. (Owner Number: 10048720)

Owner / Operator Contact Address

P.O Box 2022, Fort Collins, CO 80522, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

IVEA MODEL 600A IVEA IVEA MODEL 600S IVEA MODEL 500A IVEA O2 Tank Booster Accessory

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2015-02-17

Official Correspondent

Trevor Carlton

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

FIREFLY MEDICAL, INC.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011390406. Last updated year: 2026. Please use registration number 3011390406 when referencing this establishment in official correspondence.