O&M Halyard, Inc. (La Ada de Acuna)

FDA Device Registration & Listing · Del Rio, TX, US · Registration 3016849443

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3016849443
FEI Number
3016849443
Entity Name
O&M Halyard, Inc. (La Ada de Acuna)
City/State/Country
Del Rio, TX, US
Establishment Address
14 Finegan Road, Del Rio, TX 78840, US
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
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL Fluidshield* 2 Fog-Free Surgical Mask (62113); Fluidshield* 2 Fog-Free Surgical Mask with Wraparound Visor (62114) Fluidshield* 2 Procedure Mask with SO SOFT* Earloops and WrapAround Visor (62116) 62115 HALYARD* FLUIDSHIELD* Level 2 Procedure Mask Fluidshield* 2 Procedure Mask with SO SOFT* Earloops (62115) FLUIDSHIELD* 3 N95 Particulate Filter Respirator and Surgical Mask HALYARD Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Earloops HALYARD Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Earloops, WrapAround Visor HALYARD Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining HALYARD Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor HALYARD Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with Visor HALYARD Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining, with Visor HALYARD Fluidshield* 3 Fog-Free Surgical Mask with SO SOFT* Lining, Anti-Glare WrapAround Visor HALYARD Fluidshield * 3 Surgical Mask with SO SOFT* Lining HALYARD Fluidshield* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops HALYARD Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, WrapAround Visor SURGICAL MASK FLUIDSHIELD* 2 Procedure Mask with SO SOFT* Earloops FLUIDSHIELD* 2 Fog-Free Procedure Mask with SO SOFT* Earloops, Blue, WrapAround Visor FLUIDSHIELD* 2 Fog-Free Surgical Mask, Blue with Orange Print FLUIDSHIELD* 2 Fog-Free Surgical Mask, Blue with Orange Print, WrapAround Visor FLUIDSHIELD* 2 Procedure Mask with SO SOFT* Earloops, Blue Fluidshield* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Orange

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MSH Respirator, Surgical General, Plastic Surgery Class 2 878.4040 2018-05-02
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2024-07-29
MSH Respirator, Surgical General, Plastic Surgery Class 2 878.4040 2024-01-23
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2025-06-27
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2018-05-02

Official Correspondent

Angela Bunn

US Agent Details

No US Agent registered (Local establishment).

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
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
3005997949 La Ada De Acuna, S. de. R. L. de C. V. COL.EDUCATIVA,NOGALES Sonora, MX

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K102092 Prestige Ameritech PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES 2010-10-06
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016849443. Last updated year: 2026. Please use registration number 3016849443 when referencing this establishment in official correspondence.
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