Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2024351

FEI Number

2024351

Entity Name

INFAB, LLC.

City/State/Country

CAMARILLO, CA, US

Establishment Address

1040 Avenida Acaso, CAMARILLO, CA 93012, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

INFAB, LLC (Owner Number: 2024351)

Owner / Operator Contact Address

1040 Avenida Acaso, --, Camarillo, CA 93012, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

INFAB Mobile Radiation Protection Barriers and Shields Smart Armor apron Isolation Gown UnderShield Supplemental Radiation Shielding Garment Kerr Total Care Patient Transfer Device Lightning Aprons Classic Aprons Revolution Aprons Revolution gloves Leaded Eyewear

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EAK	Screen, Leaded, Operator Radiation Protector	Radiology	Class 1	892.6500	2024-05-17
EAJ	Apron, Leaded	Radiology	Class 1	892.6500	1998-05-20
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-05-07
KPY	Shield, Protective, Personnel	Radiology	Class 1	892.6500	2025-08-18
IWO	Apron, Protective	Radiology	Class 1	892.6500	2019-04-25
FMR	Device, Transfer, Patient, Manual	General Hospital	Class 1	880.6785	2024-01-31
KPY	Shield, Protective, Personnel	Radiology	Class 1	892.6500	2023-03-24
IWP	Radiographic Protective Glove	Radiology	Class 1	892.6500	2009-06-23
IWS	Shield, Eye, Radiological	Radiology	Class 1	892.6500	2025-12-10

Official Correspondent

Javier Rico

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

INFAB, LLC

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 2024351. Last updated year: 2026. Please use registration number 2024351 when referencing this establishment in official correspondence.