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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 47 of 52

Device	Model / Reference	Registries	Class	Status
Gastrostomy Tube, 3 port, 20fr, NON-ENFit	5122	FDA UDI	Class II	Active
IV Pole	10555-2HB	FDA UDI	Class I	Active
Allergy Tray	6936	FDA UDI	Class II	Active
Barrier Film	4489	FDA UDI	Class I	Active
Bariatric Plus Foam Mattress 48" x 80"	10432	FDA UDI	Class I	Active
Resp-O2 Endotracheal Tube, Uncuffed, 3.0 mm	36222	FDA UDI	Class II	Active
Syringe w/Needle, Non-Toxic, 21G x 1" , Luer Lock	6997	FDA UDI	Class II	Active
Isolation Gown Impervious, White, Small	2144	FDA UDI	Class I	Active
DynaSafety Heavy Duty Woven Fabric Bandages, Sterile, 7/8" x 3"	3767BULK	FDA UDI	Class I	Active
Resp-O2 Spring Loaded T-Adaptor, 15 mm ID x 15mm OD	34502	FDA UDI	Class I	Active
DynaSafety Blue Metal Detectable Plastic Strips, 1" x 3"	3764	FDA UDI	Class I	Active
DynaSafety Non-woven Adhesive Tape, 1/2" x 2 1/2yd	3581UB-2	FDA UDI	Class I	Active
Headboard	12901-OA	FDA UDI	Class II	Active
Resp-O2 Mucus Specimen Trap, Leak Proof Transport Cap, 40 cc, Sterile	32270	FDA UDI	Class II	Active
Resp-O2 Nasal Oxygen Cannula Cushion Tip with Ultra Soft Ear Foam	33155	FDA UDI	Class I	Active
Surgical Gowns	8194	FDA UDI	Class II	Active
Safety Syringe w/Needle	6924	FDA UDI	Class II	Active
SecureSafe Syringe With Safety Needle	8916	FDA UDI	Class II	Active
DynaRide S 3 Lite Wheelchair 18"x16"-18 Flip Desk Arm ELR	10230	FDA UDI	Class I	Active
Sphygmomanometer With Zipper Case, Adult/Large (Arm)	7108	FDA UDI	Class II	Active
Laryngeal Mask Airways	5042	FDA UDI	Class I	Active
Resp-O2 Laryngeal Mask Airways Silicone Reinforced, Size 1.5 mm	36286	FDA UDI	Class I	Active
Resp-O2 Oxygen Mask Non-Rebreather, Elongated Adult with Safety Vent	33050	FDA UDI	Class I	Active
Clip-On Staff Control Adapter	12923	FDA UDI	Class II	Active
Folding Bedside Commode	10372	FDA UDI	Class I	Active
DynaRest Airfloat 300 Air Mattress with Pump	10442	FDA UDI	Class II	Active
Ever-Soft Foam Cushion	10644	FDA UDI	Class I	Active
True Advantage 4 Mil Nitrile Powder Free Examination Gloves	6504	FDA UDI	Class I	Active
Lap Sponge, Sterile, Pre-Washed	3146	FDA UDI	Class I	Active
Child Face Masks	2207-CHPK	FDA UDI	Class I	Active
Black Bibs	4496	FDA UDI	Class I	Active
Resp-O2 Venturi Adjustable Dial Elongated Adult Mask	33072	FDA UDI	Class I	Active
DynaFoam Waterproof Bordered Foam Dressing	3037	FDA UDI	Class I	Active
My Doggy Compressor Nebulizer	5608DG	FDA UDI	Class II	Active
Bubble Air Mattress Pad	10470	FDA UDI	Class II	Active
Foley Catheters	4938	FDA UDI	Class II	Active
Headrest Table Paper, Smooth, White, 8" x 225'	4479	FDA UDI	Class I	Active
Elastic Tape, 4" x 5yd	3670	FDA UDI	Class I	Active
DynaSafety Waterproof Adhesive Tape 1" x 2.5yds	3652	FDA UDI	Class I	Active
U-Sling without Head Support - Small	10744SM	FDA UDI	Class I	Active
Resp-O2 Adult Manual Pulmonary Resuscitator(MPR)Mask, Reservoir Bag Oxygen Tubing	36000	FDA UDI	Class II	Active
Resp-O2 Breathable-Foam Trach Tube Holder, 1 PC, Adult, Neck 13-19"/33-48 cm	35033	FDA UDI	Class I	Active
DynaSafety Flexible Fabric Adhesive Bandages Sterile with Non-Stick Pad	3611-50	FDA UDI	Class I	Active
Medi-Cut Safety Scalpel	4165	FDA UDI	Class I	Active
Resp-O2 Heat Moisture Exchanger (HMEF) 1500 and HEPA Filter, CO2 Port	30112	FDA UDI	Class II	Active
EZ Trach Tie	4614	FDA UDI	Class I	Active
Plastic Headrest Covers	2153	FDA UDI	Class I	Active
Resp-O2 M24 Oxygen E-Cylinder 4.6 L with CGA870 Toggle Valve	36390	FDA UDI	Class I	Active
Resp-O2 Tracheostomy Pediatric Flex Connector 15mmODx 15mm ID	30602	FDA UDI	Class I	Active
Gastrostomy Tube, 3 Port, 22fr, NON-ENFit	5123	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.