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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 26 of 52

Device	Model / Reference	Registries	Class	Status
Syringes Without Needle, Non-Toxic, 60 ML, Luer Lock	6993	FDA UDI	Class II	Active
Nurse Cap	2113	FDA UDI	Class I	Active
DynaSafety Butterfly Wound Closures Sterile with Non-Stick Pad	3615UB-10	FDA UDI	Class I	Active
Shoe Cover	2131	FDA UDI	Class I	Active
Resp-O2 Oxygen Mask Medium-Concentration, Standard Pediatric	33003	FDA UDI	Class I	Active
LabChoice Specimen Containers, 60 mL, Non-Sterile	43021	FDA UDI	Class I	Active
Resp-O2 Heat Moisture Exchanger (HME) 1500 Tracheostomy	30305	FDA UDI	Class I	Active
Oral Airways, Disposable	4747	FDA UDI	Class I	Active
LabChoice Universal Container, Polypropylene, 30 mL	43051	FDA UDI	Class I	Active
IV Administration Set, Non-Toxic, 15 mL, 106" (269 cm)	7033	FDA UDI	Class II	Active
Resp-O2 Comfort-Foam Trach Tube Holder, Anti-Disconnect, 1 PC, Adolescent & Adult	35025	FDA UDI	Class I	Active
Resp-O2 Yankauer Suction Handle, Bulb Tip, Non-Vented, Sterile	32121	FDA UDI	Class II	Active
Oral Airways, Disposable	4735	FDA UDI	Class I	Active
Resp-O2 Suction Catheter Kit, 12 FR, Sterile	32053	FDA UDI	Class I	Active
Resp-O2 (HEPA) Filter	30401	FDA UDI	Class I	Active
Sterile Gauze Pad - All Gauze	3353-25	FDA UDI	Class I	Active
DynaSafety Gauze Roll Bandage, Sterile, 4"	3194UB-1	FDA UDI	Class I	Active
SecureSafe Safety Hypodermic Needles	8970	FDA UDI	Class II	Active
Gastrostomy Tube, 3 port, 18fr, ENFit	5114	FDA UDI	Class II	Active
Safety Insulin Syringes	6904	FDA UDI	Class II	Active
DynaSafety Blue Metal Detectable Woven Bandages, 1" x 3"	3760	FDA UDI	Class I	Active
Ever-Soft Air Cushion	10610	FDA UDI	Class I	Active
Long Term Low Bed, w/Central Locking System & Nurse Control	10414	FDA UDI	Class II	Active
DispoSafety Medical Waste Sharps Container	4632	FDA UDI	Class II	Active
CurPro Silk Sutures Natural Material, Braided Black, Nonabsorbable	9142	FDA UDI	Class II	Active
Full Body Sling w/Commode Opening, Mesh Large	10742LG	FDA UDI	Class I	Active
Cotton Roll	3166	FDA UDI	Class I	Active
Sphygmomanometer With Zipper Case, Adult/XL (Thigh)	7109	FDA UDI	Class II	Active
SiliGentle AG Silver Silicone Foam Dressing	3085	FDA UDI	U	Active
Bandage Shears	4185	FDA UDI	Class I	Active
IV Pole	10555-4HB	FDA UDI	Class I	Active
RespO2 Pediatric Manual Pulmonary Resuscitator (MPR) Mask, Reservoir Bag Oxygen	36007	FDA UDI	Class II	Active
Lab Coats Knitted Cuffs & Collar with Pockets, Large, Blue	2074	FDA UDI	Class I	Active
Bariatric Foot Stool	10551	FDA UDI	Class I	Active
SecureSafe Syringes With Safety Needle	8919	FDA UDI	Class II	Active
Sterile Nitrile Surgical Gloves	6534	FDA UDI	Class I	Active
Hemostat Gauze Dressing	3687	FDA UDI	U	Active
Resp-O2 Oxygen CO2 Elongated Adult Mask, CO2 Sampling Line with Filter	33080	FDA UDI	Class II	Active
DynaSafety Blue Metal Detectable Woven Fingertip Bandages Sterile	3762UB-10	FDA UDI	Class I	Active
CozyTherm Heat Relief Patch, Neck	1458	FDA UDI	Class I	Active
DynaSafety Sheer Plastic Adhesive Bandages Sterile with Non-Stick Pad	3602UB-16	FDA UDI	Class I	Active
Resp-O2 Disposable Guedel Airway, 80 mm, Adult Small, Green	36319	FDA UDI	Class I	Active
Resp-O2 Air Cushion Mask with Valve, Size #0, Preemie/Neonatal	36030	FDA UDI	Class I	Active
Sterilization Pouches	4463	FDA UDI	Class II	Active
Lab Coats Knitted Cuffs & Collar with Pocket, Medium, White	2063	FDA UDI	Class I	Active
DynaRest Foam Mattress	10430	FDA UDI	Class I	Active
Resp-O2 Air Cushion Mask with Valve, Size #5, Large Adult (Blue Hook)	36035	FDA UDI	Class I	Active
DynaLube, Sterile, 4 oz. Tube	1254	FDA UDI	Class I	Active
DMECare Solutions Solid Seat Insert	13041-22	FDA UDI	Class I	Active
Standard Nasal Cannulas (straight)	5205	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.