Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014759854

FEI Number

3014759854

Entity Name

CERTA DOSE

City/State/Country

Denver, CO, US

Establishment Address

2590 Welton Street, #200, Denver, CO 80205, US

Establishment Type(s)

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

Owner / Operator

CD Acquisitions, LLC (Certa Dose) (Owner Number: 10058186)

Owner / Operator Contact Address

2590 Welton Street, #200, Denver, CO 80205, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K160589

PMA Number

N/A

All Registered Proprietary Names

Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PQX	Epinephrine Syringe	General Hospital	Class 2	880.5860	2018-09-24

Official Correspondent

Caleb Hernandez

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CD Acquisitions, LLC (Certa Dose)

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 3014759854. Last updated year: 2026. Please use registration number 3014759854 when referencing this establishment in official correspondence.