Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012535730

FEI Number

3012535730

Entity Name

Amerx Healthcare Corp

City/State/Country

Oldsmar, FL, US

Establishment Address

164 Douglas Road East, Oldsmar, FL 34677, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Amerx Health Care Corporation (Owner Number: 10029882)

Owner / Operator Contact Address

164 Douglas Road East, Oldsmar, FL 34677, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Hydrocolloid pad thin 4 x 4 Hydrocolloid pad thin 2 x 2 Hydrocolloid pad 2 x 2 Hydrocolloid pad 4 x 4 Amerigel Ointment Calcium Alginate Pad 4 x 4 Foam 4 x 4 Foam with adhesive 4 x 4 Foam 2 x 2 Foam with adhesive 2 x 2 Wound Wash Amerigel Ointment Saturated Wound D Extremit-Ease (various sizes) 2x2 non-sterile non-woven 4 ply gauze Bordered Gauze Dressing 1 x 1 Bordered Gauze Dressing 4.25 x 4.25 Bordered Gauze Dressing 2 x 2 Bordered Gauze Dressing 4 x 10 1x3 fabric bandage 1.5x3 H Shaped Bandage 1x5 cohesive wrap (flex tape)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2015-02-24
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2016-01-13
MGQ	Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic	Unknown	Class U	N/A	2009-07-09
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2015-10-13
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2026-06-11
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2026-06-11
MGQ	Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic	Unknown	Class U	N/A	2009-07-09
FQL	Stocking, Medical Support (For General Medical Purposes)	General Hospital	Class 1	880.5780	2017-02-16
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2015-05-23
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2015-05-23

Official Correspondent

Lisa Capote

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Amerx Health Care Corporation

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
K112888	Kensey Nash Corporation	MESO WOUND MATRIX	2012-02-10
K040211	Collagen Matrix, Inc.	MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING	2004-02-27
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31
K954741	Derma Sciences, Inc.	DERMAGRAN WENT DRESSING (DEXTROSE-SALINE)	1995-11-01
K213616	Becton, Dickinson and Company	BD Surgiphor Antimicrobial Irrigation System	2022-03-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019	COVIDIEN LLC	1	Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0016-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0017-2019	COVIDIEN LLC	1	Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012535730. Last updated year: 2026. Please use registration number 3012535730 when referencing this establishment in official correspondence.