Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004932373

FEI Number

3004932373

Entity Name

CareFusion 213 LLC

City/State/Country

EL PASO, TX, US

Establishment Address

1550 NORTHWESTERN DR., EL PASO, TX 79912, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

CAREFUSION (Owner Number: 10030506)

Owner / Operator Contact Address

75 N Fairway Dr, Vernon Hills, IL 60061, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K253445

PMA Number

N/A

All Registered Proprietary Names

Surgiphor 1000mL

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2026-03-03
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2026-03-03

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CAREFUSION

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9680904	CareFusion D.R. 203 Ltd.	SANTO DOMINGO Distrito Nacional, DO
1625685	CAREFUSION 2200, INC.	Mannford, OK, US
1423507	CAREFUSION 2200, INC.	Vernon Hills, IL, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K213616	Becton, Dickinson and Company	BD Surgiphor Antimicrobial Irrigation System	2022-03-23
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R

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3009217531	Eurofins STERIPAC GMBH	Calw-Altburg Baden-Wurttemberg, DE
1718850	LivaNova USA, INC.	ARVADA, CO, US
3045076544	BEIJING YUEWEI MEDICAL TECHNOLOGY CO., LTD	Beijing, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004932373. Last updated year: 2026. Please use registration number 3004932373 when referencing this establishment in official correspondence.