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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 39 of 52

Device	Model / Reference	Registries	Class	Status
Cervical Collar	4362	FDA UDI	Class I	Active
Sensi-Wrap, Self Adherent	3186	FDA UDI	Class I	Active
10495 - Remote Control, 5 Function Bed, Replacement, 1/Cs	10495	FDA UDI	Class II	Active
Headrest Table Paper, Crepe, 8" x 125', White	4484	FDA UDI	Class I	Active
Dressing Retention Sheet	3542	FDA UDI	Class I	Active
Post-Op Plus Sponge	3355	FDA UDI	Class I	Active
Lab Coats Knitted Cuffs & Collar with Pockets, X-Large, Teal	2095	FDA UDI	Class I	Active
LabChoice Specimen Bags, 6" x 9", 1.8 MIL, Non-Sterile	8020	FDA UDI	Class I	Active
Ever-Soft Pommel Wedge Gel Foam Cushion	10680	FDA UDI	Class I	Active
Dental Bibs	4492	FDA UDI	Class I	Active
LabChoice Tube Rack, 60 Holes, Fits 17 mm Tubes	42132	FDA UDI	Class I	Active
DynaSafety Flexible Fabric Adhesive Bandages Sterile with Non-stick Pad	3612BULK	FDA UDI	Class I	Active
Resp-O2 Endotracheal Tube With Stylette Cuffed, 8.5 mm	36254	FDA UDI	Class II	Active
Nitrile Gloves, Powder Free	2618	FDA UDI	Class I	Active
LabChoice Pet Cell Bottle, 500 mL	43151	FDA UDI	Class I	Active
Air Mattress, Compact Dial Operated Pump, Single Cell	10441	FDA UDI	Class II	Active
Resp-O2 Closed Suction Tracheostomy Catheters Sterile	31001	FDA UDI	Class I	Active
SecureSafe Safety Hypodermic Needles	8973	FDA UDI	Class II	Active
Resp-O2 Comfort-Foam Trach Tube Holder 1PC, Neonatal & Infant, Neck 7"-9"/18-23cm	35020	FDA UDI	Class I	Active
Plastic Overbed Table	10457CH	FDA UDI	Class I	Active
Tongue Depressor	4312	FDA UDI	Class I	Active
Resp-O2 Oxygen CO2 Pressure Line Filters	33087	FDA UDI	Class II	Active
DynaSafety Blue Metal Detectable Woven Fingertip Bandages, 2" x 3" XL	3761UB-6	FDA UDI	Class I	Active
LabChoice Centrifuge Tubes, Polypropylene, 50 ML, Sterile	42103	FDA UDI	Class I	Active
DynaGo Quad 8 - Aluminum Rollator with 7.5" Wheels	10202	FDA UDI	Class I	Active
Resp-O2 Closed Suction Endotracheal Catheters, Sterile	31030	FDA UDI	Class I	Active
Resp-O2 Laryngeal Mask Airways Silicone Reinforced, Size 2.0 mm	36288	FDA UDI	Class I	Active
Resp-O2 Endotracheal Tube With Stylette, Uncuffed, 2.5 mm	36228	FDA UDI	Class II	Active
LabChoice Transfer Pipettes, Pediatric, Transparent, 1.5mL	40200	FDA UDI	Class I	Active
Universal Q-Bar Bed Rail	10465	FDA UDI	Class II	Active
Universal Mattress Cover with Defined Perimeter, 80" x 36" x 6"	10485	FDA UDI	Class I	Active
DynaSafety Trauma2 Tourniquets	3135	FDA UDI	Class I	Active
Resp-O2 Oxygen Tubing 5-7 mm End Adaptors	33304	FDA UDI	Class I	Active
Dyna-Safety Nitrile Exam Gloves, Powder-Free, Blue, X-Large	2624	FDA UDI	Class I	Active
Blood Collection Set	8950	FDA UDI	Class II	Active
Bubble Humidifier	5701	FDA UDI	Class II	Active
Sterile Nitrile Examination Glove	6523	FDA UDI	Class I	Active
Endotracheal Tubes	4536	FDA UDI	Class II	Active
10492 - Headboard/Footboard, Long Term Low Bed, Amber Cherry, 1pr/Cs	10492	FDA UDI	Class II	Active
Suction Canister	4671	FDA UDI	Class II	Active
Resp-O2 EtCO2 Nasal Sampling Cannulas	33187	FDA UDI	Class II	Active
Resp-O2 Tracheostomy Care Kit, One-Compartment Mini-Tray, Sterile	35009	FDA UDI	Class I	Active
Sensi-Wrap, Self Adherent	3304	FDA UDI	Class I	Active
Laryngeal Mask Airways	5033	FDA UDI	Class I	Active
DynaRest Home Foam Mattress	10434	FDA UDI	Class I	Active
SensiLance-Button Activated Safety Lancets	7124	FDA UDI	Class II	Active
DynaDerm Hydrocolloid Dressing	3014	FDA UDI	Class I	Active
Lab Jackets Knitted Cuffs & Collar With Pockets, 2X-Large, Blue	2016	FDA UDI	Class I	Active
Flexible Fabric Bandages	3614	FDA UDI	Class I	Active
Resp-O2 Extended Oxygen Regulator CGA 870 Style	36358	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.