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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 45 of 52

Device	Model / Reference	Registries	Class	Status
Oval Eye Pads, Sterile	3359	FDA UDI	Class I	Active
10477 - Headboard/Footboard, Long Term Care beds, Light Oak, 1pr/Cs	10477	FDA UDI	Class II	Active
Suction Catheter Kits, Disposable	4830	FDA UDI	Class I	Active
DynaSafety Waterproof Adhesive Tape 1/2" x 2.5yds	3651	FDA UDI	Class I	Active
Resp-O2 Closed Suction Tracheostomy Catheters, T-Piece	31000	FDA UDI	Class I	Active
DMECare Solutions Ever-Soft Lumbar Support Cushion, 20"	13042-20	FDA UDI	Class I	Active
Replacement Mattress Cover for 10424 & 10428	10487	FDA UDI	Class I	Active
LabChoice Microscope Slides, 75mm x 25mm x 1mm, Clear	4170	FDA UDI	Class I	Active
LabChoice Plastic Test Tubes, Polypropylene, 13 x 75 mm	42003	FDA UDI	Class I	Active
Wheelchair Lap Hugger	13030	FDA UDI	Class I	Active
Sensi-Wrap, Self Adherent	3283	FDA UDI	Class I	Active
10494 - Remote Control, 3 Function Bed, Replacement, 1/Cs	10494	FDA UDI	Class II	Active
Resp-O2 Air Cushion Mask with Valve, Size #1, Neonate/Infant	36031	FDA UDI	Class I	Active
Headboard	12900-OA	FDA UDI	Class II	Active
Hypodermic Needles, Non-Toxic, 22G x 1"	6968	FDA UDI	Class II	Active
Dyna-Stopper Multi-Purpose wound and Trauma Dressing	3535	FDA UDI	Class I	Active
Resp-O2 Laryngeal Mask Airways Silicone, Non-Reinforced, Size 2.0 mm	36295	FDA UDI	Class I	Active
Resp-O2 Oxygen Mask High-Concentration, Elongated Pediatric	33013	FDA UDI	Class I	Active
Resp-O2 Nasal Oxygen Cannula, Standard Tip	33108	FDA UDI	Class I	Active
Disposable Foam Head Blocks	5626	FDA UDI	Class I	Active
Endotracheal Tubes	4537	FDA UDI	Class II	Active
Endotracheal Tubes	4559	FDA UDI	Class II	Active
Footboard	12912-OA	FDA UDI	Class II	Active
Endotracheal Tubes	4552	FDA UDI	Class II	Active
Homecare Adjustable Full Length Bed Rail	10463	FDA UDI	Class I	Active
Hypodermic Needle	6963	FDA UDI	Class II	Active
Oxygen Concentrator	10800	FDA UDI	Class II	Active
Sensi-Wrap, Self Adherent	3299	FDA UDI	Class I	Active
Sterile Surgical Sponges	3322	FDA UDI	Class I	Active
Resp-O2 Oxygen Mask Non-Rebreather, Elongated Pediatric	33053	FDA UDI	Class I	Active
SecureSafe Safety Hyperdermic Needles	8960	FDA UDI	Class II	Active
Cotton Stockinette	3696	FDA UDI	Class I	Active
Disposable Scrub Pants	1979	FDA UDI	Class I	Active
Safety Syringe w/Needle	6921	FDA UDI	Class II	Active
Sterile Nitrile Surgical Gloves	6538	FDA UDI	Class I	Active
Sensi Wrap, Self-Adherent - Latex Free 3" x 5 yds Light Blue	3318	FDA UDI	Class I	Active
Overbed Table H Base, Silver Vein, Walnut	10450-WN	FDA UDI	Class I	Active
Endotracheal Tubes	4556	FDA UDI	Class II	Active
Surgical Gowns	8195	FDA UDI	Class II	Active
Laryngeal Mask Airways	5032	FDA UDI	Class I	Active
SecureStrip Adhesive Wound Closures	3525	FDA UDI	Class I	Active
Foley Catheters	4952	FDA UDI	Class II	Active
Pre-Bent Flow Tips	2212	FDA UDI	Class I	Active
Resp-O2 Nasal Oxygen Cannula Cushion Tip with Ultra Soft Ear Foam	33152	FDA UDI	Class I	Active
DynaSafety Blue Metal Detectable Woven Bandages, 1" x 3"	3760UB-16	FDA UDI	Class I	Active
Gait Belt	4344	FDA UDI	Class I	Active
Sensi Grip Powder Free Exam Gloves	6712	FDA UDI	Class I	Active
IV Administration Set, 60 mL, Non-Toxic	7051	FDA UDI	Class II	Active
DynaLift Transport Unit	5620	FDA UDI	Class I	Active
Perineal Instant Cold Pack with self adhesive strip	4515	FDA UDI	Class I	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.