Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8030672

FEI Number

3194

Entity Name

Cirpro de Delicias S. de R.L. de C.V.

City/State/Country

DELICIAS Chihuahua, MX

Establishment Address

Calle Parque Industrial Las Virgenes S/N, Colonia Parque Industrial Las Virgenes, DELICIAS Chihuahua 33018, MX

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Cardinal Health 200, LLC (Owner Number: 9028292)

Owner / Operator Contact Address

3651 Birchwood Drive, --, Waukegan, IL 60085, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K200824

PMA Number

N/A

All Registered Proprietary Names

Stainless Steel Tongue Cleaner

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2017-06-19
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2015-06-02
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2015-05-14
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2016-09-15
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2017-12-05
ILG	Stocking, Elastic	Physical Medicine	Class 1	890.3475	2003-07-01
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2017-08-08
KGW	Ring (Wound Protector), Drape Retention, Internal	General, Plastic Surgery	Class 2	878.4370	2017-08-11
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2017-03-07
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	2026-06-12
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2015-05-14
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2005-09-06
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2023-08-07
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2009-05-06
OJH	Orthopedic Tray	General, Plastic Surgery	Class 1	878.4800	2009-05-07
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2006-04-11
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2015-04-29
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2008-04-15
HHK	Curette, Suction, Endometrial (And Accessories)	Obstetrics/Gynecology	Class 2	884.1175	2008-06-11
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2022-07-20

Official Correspondent

No official correspondent registered.

US Agent Details

Stacey Henning Email: stacey.henning@cardinalhealth.com Phone: (312) 2702081

Related Public Records

Same Entity

Cardinal Health 200, LLC

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004839227	Cardinal Health Malta 212 Ltd	Marsa, MT
3015541720	Cardinal Health Germany Manufacturing GmbH	Halberstadt Saxony-Anhalt, DE
1033903	Cardinal Health	Greenwood, SC, US
9611018	Cardinal Health Ireland Manufacturing Limited	TULLAMORE Offaly, IE
8040459	Kendall-Gammatron Limited	SAMPRAN Nakhon Pathom, TH

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K892118	Paramount Products, Inc.	NON-STERILE MASKS AND CAPS	1989-04-20
K961683	J.J. Skinner, Inc.	JJ SKINNER CAREKITS MINOR SURGICAL PROCEDURE TRAY	1996-05-10
K201622	Guangdong Kingfa Sci. & Tech.Co., Ltd.	Medical surgical mask	2020-11-24
K881618	3M Company	ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK	1988-05-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2013	Accuro Medical Product LLC	2	Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump; Accuro Medical Products LLC, 2854 Hitchcock Ave, Downers Grove, IL 60515; part number 84635400182, sold inside the Apex Negative Wound Therapy system, part number 84635400181 Promotes wound healing through drainage and removal of infectious material and other fluids from the wound site using continuous and/or intermittent negative pressure. Types of wounds indicated include diabetic/neuropathic ulcers, pressure ulcers, chronic wounds, acute wounds and dehisced wounds.
Z-0039-2015	Smith & Nephew, Inc.	2	RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
Z-0040-2015	Smith & Nephew, Inc.	2	RENASYS EZ/ RENASYS EZ Plus 800 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
Z-0041-2015	Smith & Nephew, Inc.	2	RENASYS EZ/ RENASYS EZ Plus 800 mL canister (w/o CLP) with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
Z-0027-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8030672. Last updated year: 2026. Please use registration number 8030672 when referencing this establishment in official correspondence.