Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005997949

FEI Number

3005997949

Entity Name

La Ada De Acuna, S. de. R. L. de C. V.

City/State/Country

COL.EDUCATIVA,NOGALES Sonora, MX

Establishment Address

AV. HIDALGO No. 6 ESQ., BLVD. LUIS DONALDO COLOSIO, COL.EDUCATIVA,NOGALES Sonora 84093, MX

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

O&M Halyard, Inc. (Owner Number: 10057479)

Owner / Operator Contact Address

1220 Old Alpharetta Rd, Suite 320, Alpharetta, GA 30005, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

HALYARD BASICS SURGICAL GOWN HALYARD PROCEDURE GOWN SURGICAL DRAPE Surgical Packs SURGICAL DRAPE Surgical Packs Anesthesia Breathing Circuit Kit (Adult & Pediatric) General Surgery Tray

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	2018-05-18
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2018-05-18
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2018-04-27
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2018-05-31
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2018-05-31
OFP	Anesthesia Breathing Circuit Kit (Adult & Pediatric)	Anesthesiology	Class 1	868.5240	2025-08-25
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2022-02-15

Official Correspondent

Angela Bunn

US Agent Details

ANGELA BUNN Business: O&M HALYARD, INC. Email: angela.bunn@owens-minor.com Phone: (470) 3647147

Related Public Records

Same Entity

O&M Halyard, Inc.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3012143814	Southaven Distribution Center	Southaven, MS, US
3016849443	O&M Halyard, Inc. (La Ada de Acuna)	Del Rio, TX, US
1054380	Halyard North Carolina, LLC	LINWOOD, NC, US
9680646	O&M Halyard Honduras S.A de C.V.	VILLANEVA Cortes, HN
3035642068	Honduras Kitting, S.A.	Villanueva Cortes, HN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K892118	Paramount Products, Inc.	NON-STERILE MASKS AND CAPS	1989-04-20
K914369	Deroyal Industries, Inc.	QUALTEX MAGNETIC INSTRUMENT DRAPE	1991-12-02
K812809	Abco Dealers, Inc.	STERILE ADHERENT DRAPES	1981-11-06
K910084	Biocor Medical, Inc.	SURGICAL DRAPE	1991-03-19
K961683	J.J. Skinner, Inc.	JJ SKINNER CAREKITS MINOR SURGICAL PROCEDURE TRAY	1996-05-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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.
Z-0028-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0030-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical T and A Pack REF AMS11482 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0031-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0095-2021	Alcon Research, LLC	2	Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXIS" Latex Micro Surgical Gloves - Product Usage: used by ophthalmic surgeons in a variety of ophthalmic surgeries.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005997949. Last updated year: 2026. Please use registration number 3005997949 when referencing this establishment in official correspondence.