Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009540516

FEI Number

3009540516

Entity Name

AERO HEALTHCARE

City/State/Country

Valley Cottage, NY, US

Establishment Address

616 CORPORATE WAY STE 6, Valley Cottage, NY 10989, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Aero Healthcare (Owner Number: 10040045)

Owner / Operator Contact Address

616 Corporate Way, Suite 6, Valley Cottage, NY 10989, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

AEROPAD Low Adherent Dressing AEROPLAST Amputated Parts Bags AEROFILM Waterproof Film Dressing AEROPLAST Plastic Bandages AEROPLAST Fabric Bandages AEROPLAST Blue Detectable Bandages AEROPINS Safety Pins AEROWOUND Combine Trauma Dressing AERO Stainless Steel Tweezers AEROPAD Eye Pad AEROPLAST Emergency Thermal Blanket AEROMASK AEROSHIELD Disposable Face Shield AEROSHIELD Keyring CPR Face Shield AEROMASK CPR Mask AEROSWAB Gauze Swabs AEROBURN AEROWOUND Wound Dressing Bandage Scissors Wire Scissors Lister Scissors AEROPLAST Disposable Ice Pack First Aid Kits and Bags, Procedure Packs AEROBAND Triangular Bandage AEROBURN Packets, 4"x4" Dressing AEROWIPE Cleansing Wipes AEROSWAB Cotton Tip Applicators

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2012-03-20
KGY	Bag, Intestine	General, Plastic Surgery	Class 1	878.4100	2012-07-07
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2012-03-20
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	2012-07-07
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2012-03-03
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2025-08-07
FQZ	Thermometer, Clinical Color Change	General Hospital	Class 1	880.2900	2025-01-07
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2012-07-07
HMP	Pad, Eye	General, Plastic Surgery	Class 1	878.4440	2012-08-20
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2012-03-29
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2012-03-29
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2012-03-29
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2012-03-15
FPY	Sheet, Burn	General Hospital	Class 1	880.5180	2012-04-11
MHW	Dressing, Compression	General Hospital	Class 1	880.5075	2025-01-07
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2019-09-10
JOK	Scissors, Medical, Disposable	General Hospital	Class 1	880.6820	2012-03-20
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2012-03-20
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2013-02-01
KPD	Strip, Temperature, Forehead, Liquid Crystal	General Hospital	Class 2	880.2200	2025-01-07
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2012-04-30
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2012-03-29
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2012-07-07
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2012-03-15

Official Correspondent

Daryl Parker

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Aero Healthcare

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
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04
K831798	I M, Inc.	DISPOSABLE SCALPELS	1983-07-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0505-2022	Philips North America Llc	1	Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Z-0506-2022	Philips North America Llc	1	Infant Heel Warmers w/strap, Reference # 989805603201 1223

Similar Registrations

Registration Number	Establishment Name	Location
3027643662	ERIBIOTECH CO.,LTD	Suzhou Jiangsu, CN
3006607005	MOLNLYCKE HEALTH CARE (THAILAND), LTD.	Amphur Muang Chonburi Chon Buri, TH
3015432652	E.L.F. COSMETICS INC	Oakland, CA, US
3043138901	DONGGUAN SAMVO BIOTECHNOLOGY CO., LTD	Dongguan Guangdong, CN
3015215566	THE HAIN CELESTIAL GROUP	Hoboken, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009540516. Last updated year: 2026. Please use registration number 3009540516 when referencing this establishment in official correspondence.