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Dynarex Corp.

Last updated September 17, 2026

Information

Country: US
Address: 11 Dynarex Drive, Middletown, NY, 10941
Website: —
LinkedIn: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 2431014
DUNS Number: —

Catalogue (2572)

Page 23 of 52

Device	Model / Reference	Registries	Class	Status
Resp-O2 Small Volume Nebulizer	34100	FDA UDI	Class II	Active
Dressing Change Tray, Sterile	11001	FDA UDI	Class II	Active
Sterile Gauze Pad - All Gauze	3353-10	FDA UDI	Class I	Active
Resp-O2 Yankauer Suction Handle, Bulb Tip, Non-Vented, Sterile	32128	FDA UDI	Class II	Active
Low Overbed Table	10456	FDA UDI	Class I	Active
Cotton Tipped Wood Applicators, Sterile	4305	FDA UDI	Class I	Active
Hypodermic Needle, Non-Safety, 22G, 3/4" needles	6981	FDA UDI	Class II	Active
Nasopharyngeal Airway	4596	FDA UDI	Class I	Active
Irrigation Tray with 60cc Piston Syringe	4268	FDA UDI	Class I	Active
Pillow Cases, Tissue / Poly 2-ply, 21" x 30", White	8161	FDA UDI	Class I	Active
Suction Catheters, Disposable	4806	FDA UDI	Class I	Active
Sterile Nitrile Examination Glove	6528	FDA UDI	Class I	Active
Resp-O2 Suction Catheter Kits 16 FR Mini-Tray, Sterile	32084	FDA UDI	Class I	Active
Sensi-Wrap, Self Adherent	3176	FDA UDI	Class I	Active
Standard seat/back sling - Mesh	10750MS	FDA UDI	Class I	Active
Sphygmomanometer With Zipper Case, Infant (Under 1 Year Old)	7104	FDA UDI	Class II	Active
Endotracheal Tubes	4531	FDA UDI	Class II	Active
SecureSafe Safety Hypodermic Needles	8967	FDA UDI	Class II	Active
Non-Woven Sponge	3363	FDA UDI	Class I	Active
Greenline Cruiser Wheelchair 18" with Foot Rest	10284-FR	FDA UDI	Class I	Active
DMECare Solutions Ever-Soft Lumbar Support Cushions, 16"	13042-16	FDA UDI	Class I	Active
Closed Circuit Foley Catheter Tray	5006	FDA UDI	Class II	Active
Sterile Gauze Pad - All Gauze	3354-10	FDA UDI	Class I	Active
AccuTouch Powder Free Non-Sterile Latex Exam Gloves	6621	FDA UDI	Class I	Active
Arm Sling	4350	FDA UDI	Class I	Active
LabChoice Plastic Test Tubes, Polystyrene, 13 x 75 mm	42002	FDA UDI	Class I	Active
Resp-O2 Suction Connecting Tubing, Sterile	32112	FDA UDI	Class II	Active
Elastic Bandage with Self-Closure	3660	FDA UDI	Class I	Active
Arm Sling	4355	FDA UDI	Class I	Active
Resp-O2 Nasopharyngeal Airways, 30 FR	36280	FDA UDI	Class I	Active
Mattress Gap Filler, 4" x 6" x 48"	10572	FDA UDI	Class I	Active
Sharps Shaft	4630	FDA UDI	Class II	Active
Resp-O2 Spring Loaded T-Adaptor, 2mm ID x 22 mm OD	34501	FDA UDI	Class I	Active
Hypodermic Needle	6962	FDA UDI	Class II	Active
SiliGentle Silicone Bordered Foam Dressing	3060	FDA UDI	Class I	Active
Silicone Foley Catheters	5074	FDA UDI	Class II	Active
LabChoice Specimen Bags, Clear, 8" x 10", 1.8 MIL	8021	FDA UDI	Class I	Active
Sterile Surgical Sponges	3344	FDA UDI	Class I	Active
Ever-Soft Air Cushion	10600	FDA UDI	Class I	Active
Powder Coated Grab Bar 16"	10306	FDA UDI	Class I	Active
DynaRest Gel Foam Mattress Overlay	10438	FDA UDI	Class I	Active
Child Face Masks	2207-CHBL	FDA UDI	Class I	Active
Mattress Gap Filler, 4" x 6" x 36"	10570	FDA UDI	Class I	Active
Resp-O2 Closed Suction Tracheostomy Catheters, Sterile	31003	FDA UDI	Class I	Active
Drape Sheets	8122	FDA UDI	Class I	Active
N95 Respirator	2295	FDA UDI	Class II	Active
Durma+ Island Dressing, 4" x 13 3/4"	3074	FDA UDI	Class I	Active
Safety Syringe w/Needle	6919	FDA UDI	Class II	Active
Endotracheal Tubes	4543	FDA UDI	Class II	Active
Ridgewood Collection Home Care Full Electric ( Board )	10400BLACK-BR-2	FDA UDI	Class II	Active

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FDA Recalls (6)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
May 8, 2018	Z-1955-2018	—	terminated	The device is equipped with a dial that has an inaccurate flow rate indicator.
Mar 3, 2016	Z-2057-2016	—	terminated	Exterior carton is mis-labeled as Sterile. Non-sterile, bulk specimen containers were packed in incorrect exterior carton.
Jul 2, 2014	Z-2117-2014	—	terminated	"THIS SIDE UP" is on the wrong side of the product. This error poses a potential health hazard if the wrong labeling is followed by caregivers.
May 10, 2004	Z-0951-04	—	terminated	Bandages labeled as "100% Latex Free" may contain latex. The wrapper was analytically tested by a private laboratory and found to contain latex.
Dec 31, 2002	Z-0573-03	—	terminated	Product labeled as 'latex free' but recent tests indicate that it contains minute amounts of latex.
Dec 31, 2002	Z-0572-03	—	terminated	Product labeled as 'latex free' but recent tests indicate that it contains minute amounts of latex.