Amsino Healthcare (USA) Inc.

FDA Device Registration & Listing · Vernon Hills, IL, US · Registration 1417519

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
1417519
FEI Number
1417519
Entity Name
Amsino Healthcare (USA) Inc.
City/State/Country
Vernon Hills, IL, US
Establishment Address
330 CORPORATE WOODS PARKWAY, Vernon Hills, IL 60061, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Amsino Healthcare (USA) Inc. (Owner Number: 10058949)
Owner / Operator Contact Address
330 Corporate Woods Parkway, Vernon Hills, IL 60061, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K820227
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FQH Lavage, Jet General Hospital Class 2 880.5475 2022-11-10
FRO Dressing, Wound, Drug Unknown Class U N/A 2022-11-10
FQH Lavage, Jet General Hospital Class 2 880.5475 2024-02-26
FRO Dressing, Wound, Drug Unknown Class U N/A 2024-02-26
FRO Dressing, Wound, Drug Unknown Class U N/A 2023-05-23
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2020-01-31
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2018-12-27

Official Correspondent

Esteban Encarnacion

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Amsino Healthcare (USA) Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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
K012633 Respironics, Inc. RESPIRONICS HEATED HUMIDIFIER 2002-02-28
K970478 Marquest Medical Products, Inc. SCT 3000 HEATED HUMIDIFIER 1997-07-16
K163485 Adherium (Nz), Ltd. SmartTouch 2017-08-30

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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1417519. Last updated year: 2026. Please use registration number 1417519 when referencing this establishment in official correspondence.
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