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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 27 of 52

Device	Model / Reference	Registries	Class	Status
Dynarex ActiSplint	3530	FDA UDI	Class I	Active
Geri-Chair Infinite Position Recliner	10523	FDA UDI	Class I	Active
Floor Mat Sensors Tri-Fold	P-109950	FDA UDI	Class I	Active
Combine Pads	3501	FDA UDI	Class I	Active
Resp-O2 Single Suction Catheter, 14 FR, Sterile	32004	FDA UDI	Class I	Active
DynaLevin Waterproof Adhesive Bordered Foam Dressing	3022	FDA UDI	Class I	Active
Non-Woven Sponge	3362	FDA UDI	Class I	Active
Lab Coats Knitted Cuffs & Collar with Pockets, Small, Teal	2092	FDA UDI	Class I	Active
Foley Insertion Tray	4927	FDA UDI	Class II	Active
Resp-O2 Disposable Water Trap, Pediatric, Y Cap, 15 mm, OD Tubing Connector	34203	FDA UDI	Class I	Active
Insulin Syringe	6958	FDA UDI	Class II	Active
Nasopharyngeal Airway	4593	FDA UDI	Class I	Active
LabChoice Specimen Containers, 40 mL, Non-Sterile	43020	FDA UDI	Class I	Active
Safety Syringe w/Needle	6930	FDA UDI	Class II	Active
Silicone Foley Catheters	5089	FDA UDI	Class II	Active
Trapeze Bar with Stand	10710	FDA UDI	Class I	Active
IV Start Kit	4696	FDA UDI	Class II	Active
Headboard	12902-OA	FDA UDI	Class II	Active
LabChoice Tourniquets, 1"x18" (2.5 cm x 45.7 cm)	3139	FDA UDI	Class I	Active
DynaSafety Waterproof Adhesive Tape 1" x 10yds	3656	FDA UDI	Class I	Active
Saliva Ejectors	2218	FDA UDI	Class I	Active
Ever-Soft Gel Foam Cushion	10632	FDA UDI	Class I	Active
Mini Oxygen Regulator	5215	FDA UDI	Class I	Active
Vital Signs Patient Monitor	10841	FDA UDI	Class II	Active
Safe-Touch Vinyl Examination Gloves, Powder-Free	2614	FDA UDI	Class I	Active
Insulin Syringe	6959	FDA UDI	Class II	Active
Shoe Cover	2134	FDA UDI	Class I	Active
Island Dressing- Sterile	3494	FDA UDI	Class I	Active
SecureSafe Syringe With Safety Needle	8927	FDA UDI	Class II	Active
LabChoice Transport Swabs, Snappable Polystyrene Shaft, Viscose Tip, Sterile	41153	FDA UDI	Class I	Active
Resp-O2 Nasal Oxygen Cannula Cushion Tip with Advantage Ear Foam	33171	FDA UDI	Class I	Active
Resp-O2 Oxygen Tubing Nut Nipple Adaptors	33307	FDA UDI	Class I	Active
Sensi Wrap, Self-Adherent - Latex Free, 2" X 5yd, Tan	3188	FDA UDI	Class I	Active
Yankauer with Suction Tubing	4698	FDA UDI	Class II	Active
Resp-O2 Oxygen CO2, 7'(2.1m) Sampling Line, Male / Male Connector	33083	FDA UDI	Class II	Active
Long Term Care Bed	12002	FDA UDI	Class II	Active
8943 SecureSafe Safety Blood Collection Set w/ Tube Holder, 21G, 3/4" Needle, 4/	8943	FDA UDI	Class II	Active
Powder Coated Grab Bar 18"	10307	FDA UDI	Class I	Active
Child Face Masks	2207-CHDG	FDA UDI	Class I	Active
Resp-O2 Oral Airways, Berman Type, 80 mm, Small, Green	36304	FDA UDI	Class I	Active
Nasal Sponges Sterile	3168	FDA UDI	Class I	Active
Endotracheal Tubes	4530	FDA UDI	Class II	Active
Syringe w/Needle, Non-Toxic, Luer Lock, 5 ML, 21G x 1 1/2"	7007	FDA UDI	Class II	Active
CurPro Nylon Suture, Black Monofilament, Nonabsorbable, Synthetic	9100	FDA UDI	Class II	Active
Oral Airways, Disposable	4767	FDA UDI	Class I	Active
Medi-Cut Blades #12	4132	FDA UDI	Class I	Active
Resp-O2 Endotracheal Tube, Uncuffed, 2.0 mm	36220	FDA UDI	Class II	Active
LabChoice Tube Racks, 90 Holes, Fits 13 mm Tubes	42131	FDA UDI	Class I	Active
Syringe w/Needle, Non-Toxic, 10 ML, Luer Lock, 21G x 1"	7012	FDA UDI	Class II	Active
DynaGo Advantage - Steel Rollator with 6" Wheels, Red	10205	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.