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Dynarex Corp.

Last updated September 17, 2026

Information

Country: US
Address: 11 Dynarex Drive, Middletown, NY, 10941
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 2431014
DUNS Number: —

Catalogue (2572)

Page 13 of 52

Device	Model / Reference	Registries	Class	Status
Plastic Tweezers	4918	FDA UDI	Class I	Active
Medi-Cut Blades #22	4142	FDA UDI	Class I	Active
Bariatric U-Sling with Head Support	10745XL	FDA UDI	Class I	Active
Plastic Cord Covers	2161	FDA UDI	Class I	Active
Urethral Intermittent Catheter Tray	4928	FDA UDI	Class II	Active
Foley Catheters	4948	FDA UDI	Class II	Active
Suction Canister	4675	FDA UDI	Class II	Active
Barrier Film	4488	FDA UDI	Class I	Active
Endotracheal Tubes	4545	FDA UDI	Class II	Active
Surgical Gowns	8192	FDA UDI	Class II	Active
Resp-O2 Small Volume Nebulizer 6 cc Cup	34107	FDA UDI	Class II	Active
Endotracheal Tubes	4533	FDA UDI	Class II	Active
Resp-O2 Nasal Oxygen Cannula, Flared Tip	33110	FDA UDI	Class I	Active
Raised Toilet Seat without Arms	10362	FDA UDI	Class I	Active
DynaGuard Waterproof Composite Dressing	3035	FDA UDI	Class I	Active
Resp-O2 Comfort-Foam Trach Tube Holder 2 PC, Pediatric Maximum Neck Sixe 18"/46cm	35028	FDA UDI	Class I	Active
Nasopharyngeal Airway	4599	FDA UDI	Class I	Active
Packing Strip	3402	FDA UDI	U	Active
Resp-O2 Laryngeal Mask Airways Silicone Reinforced, Size 2.5 mm	36289	FDA UDI	Class I	Active
Deluxe Sit to Stand Sling, Solid X-Large	10746XL	FDA UDI	Class I	Active
Trach Tube Holder - Pediatric (9" length)	4621	FDA UDI	Class I	Active
Sterile Nitrile Surgical Gloves	6535	FDA UDI	Class I	Active
Syringe w/Needle, Non-Toxic, 21G x 1", Luer Lock	6998	FDA UDI	Class II	Active
Resp-O2 Comfort-Form Trach Tube Holder, 1 PC, Adult, Neck 13"-19"/33-48 cm	35022	FDA UDI	Class I	Active
Long-Term Care Bed	12004-OA	FDA UDI	Class II	Active
Resp-O2 Oxygen Mask Medium-Concentration, Elongated Pediatric	33007	FDA UDI	Class I	Active
Non-Woven Sponge	3364	FDA UDI	Class I	Active
Sensi-Wrap, Self Adherent	3285	FDA UDI	Class I	Active
Ever-Soft Foam Cushion	10643	FDA UDI	Class I	Active
Resp-O2 CPAP Tubing 6' ( 1.8 m )	39122	FDA UDI	Class I	Active
Cervical Collar	4367	FDA UDI	Class I	Active
Suction Tubing w/Straw Connector	4689	FDA UDI	Class II	Active
Sensi-Wrap, Self Adherent	3183	FDA UDI	Class I	Active
Drape Sheets	8132	FDA UDI	Class I	Active
Krinkle Gauze Roll, Sterile	3161	FDA UDI	Class I	Active
Sensi-Wrap, Self Adherent	3292	FDA UDI	Class I	Active
Abdominal Binder	4370	FDA UDI	Class I	Active
DynaRest @Home Innerspring Mattress	10436	FDA UDI	Class I	Active
SecureSafe Safety Hypodermic Needles	8971	FDA UDI	Class II	Active
Bandage Shears	4191	FDA UDI	Class I	Active
Ever-Soft Wedge Gel Foam Cushion, 18"x16"x4"x2"	10625	FDA UDI	Class I	Active
DynaRide S 2 Wheelchair-16"x16" Seat w/ Detach Desk Arm FR	10220	FDA UDI	Class I	Active
DynaRide S 3 Lite Wheelchair 20"x16"-18 Flip Desk Arm ELR	10231	FDA UDI	Class I	Active
SecureStrip Adhesive Wound Closures	3521	FDA UDI	Class I	Active
Sensi Wrap, Self-Adherent - Latex Free 1" x 5 yds Pink	3310	FDA UDI	Class I	Active
Cotton Tipped Wood Applicators, Non-Sterile	4301	FDA UDI	Class I	Active
Sensi-Wrap, Self Adherent	3214	FDA UDI	Class I	Active
Syringe w/Needle, Non-Toxic, 22G x 1", Luer Lock	6999	FDA UDI	Class II	Active
Resp-O2 Oxygen Tubing Y Adaptors	33306	FDA UDI	Class I	Active
CPR Shield w/one way valve	4921	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.