Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3031981428

FEI Number

3031981428

Entity Name

Zorro-Flow Inc.

City/State/Country

Birmingham, AL, US

Establishment Address

1500 1st Avenue North, H102, Birmingham, AL 35203, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Zorro-Flow, Inc. (Owner Number: 10091293)

Owner / Operator Contact Address

1500 1st Avenue North, H102, Birmingham, AL 35223, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Zorro-Flow External Urine Collection Device ZF-F-L Zorro-Flow External Urine Collection Device ZF-F-XS Zorro-Flow External Urine Collection Device ZF-F-M Zorro-Flow External Urine Collection Device ZF-F-S

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FOC	Bag, Urine Collection, Newborn	Gastroenterology, Urology	Class 2	876.5250	2024-08-13

Official Correspondent

David Askenazi

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Zorro-Flow, 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
K911329	C.R. Bard, Inc.	BARD(R) SURECATCH PEDIATRIC URINE COLLECT DEVICE	1991-05-28

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031981428. Last updated year: 2026. Please use registration number 3031981428 when referencing this establishment in official correspondence.