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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 51 of 52

Device	Model / Reference	Registries	Class	Status
Bandage Shears	4181	FDA UDI	Class I	Active
Silicone Foley Catheters	5080	FDA UDI	Class II	Active
Abdominal Binder	4383	FDA UDI	Class I	Active
Resp-O2 Endotracheal Tube with Stylette, Uncuffed, 4.0 mm	36231	FDA UDI	Class II	Active
Full-Length Face Shield	2209	FDA UDI	Class I	Active
Resp-O2 Nasal Oxygen Cannula Cushion Tip with Ultra Soft Ear Foam	33151	FDA UDI	Class I	Active
Maxi Pads Super Thick with-Wings	1358	FDA UDI	Class I	Active
DynaGo Forearm Rollator	10214	FDA UDI	Class I	Active
Ever-Soft Air Cushion	10614	FDA UDI	Class I	Active
Resp-O2 Tracheostomy Care Kit, 3-Compartment Tray w/ Hydrogen Peroxdie	35006	FDA UDI	Class I	Active
Sensi-Wrap, Self Adherent	3272	FDA UDI	Class I	Active
SecureSafe Tuberculin Safety Syringe	8938	FDA UDI	Class II	Active
Cervical Collar	4357	FDA UDI	Class I	Active
Suction Catheters, Disposable	4816	FDA UDI	Class I	Active
Sharps Container	4624	FDA UDI	Class II	Active
Clear Surgical Tape 1" x 10 yds	3572	FDA UDI	Class I	Active
Foot Rest FR	10266	FDA UDI	Class I	Active
Standard Nasal Cannulas (flared)	5207	FDA UDI	Class I	Active
Resp-O2 Aerosol Face Tent Adult Masks	34005	FDA UDI	Class I	Active
Resp-O2 Closed Suction Endotracheal Catheters, Sterile	31031	FDA UDI	Class I	Active
Hypodermic Needle	6976	FDA UDI	Class II	Active
Cotton Tipped Wood Applicators, Sterile	4304	FDA UDI	Class I	Active
Overbed Table with U-Base	10455	FDA UDI	Class I	Active
FoamFlex Non-Adhesive Waterproof Foam Dressing	3024	FDA UDI	Class I	Active
DynaDerm Hydrocolloid Dressing	3020	FDA UDI	Class I	Active
Resp-O2 Tracheostomy Care Kit, 1-Compartment Tray without Gloves	35008	FDA UDI	Class I	Active
Suction Catheter Kits, Disposable	4828	FDA UDI	Class I	Active
Elastic Bandage with Self-Closure	3659	FDA UDI	Class I	Active
Safety Syringe w/Needle	6926	FDA UDI	Class II	Active
Bariatric Shower Chair without Back	10325	FDA UDI	Class I	Active
Sensi Wrap, Self-Adherent - Latex Free 2" x 5 yd Pink	3315	FDA UDI	Class I	Active
Resp-O2 Oxygen Mask High-Concentration, Standard Infant	33011	FDA UDI	Class I	Active
Stretch Gauze Bandage Roll, Non-Sterile	3134	FDA UDI	Class I	Active
Long-Term Care Bed	12004-CH	FDA UDI	Class II	Active
XeroBurn Sterile Burn Dressing Blanket 70" x 95"	1339	FDA UDI	Class I	Active
LabChoice Microcentrifuge Tubes, Polypropylene, 2mL, Sterile	42122	FDA UDI	Class I	Active
C-Protector, 1-Way Valve	CSM-4921	FDA UDI	Class II	Active
IV Administration Set	7039	FDA UDI	Class II	Active
Endotracheal Tubes	4562	FDA UDI	Class II	Active
Clear Surgical Tape 2" x 10 yds	3573	FDA UDI	Class I	Active
Resp-O2 Oral Airway, Berman Type, 100 mm, Large, Red	36309	FDA UDI	Class I	Active
IV Start Kit	13001	FDA UDI	Class II	Unknown
Resp-O2 Air Cushion Mask with Valve, Size #4, Medium Adult, (Red Hook)	36034	FDA UDI	Class I	Active
Aluminum Crutches - Child	10100	FDA UDI	Class I	Active
Dynarex Bari + Max Bariatric HD Home Care Half Length Bed Rail	10488	FDA UDI	Class I	Active
Yankauer Suction Handle	4694	FDA UDI	Class II	Active
Dynarex Gauze Sponge	K951660	FDA 510(k)	U	Active
Dynarex Intermittent Catheters, Male, Female, Pediatric	K103086	FDA 510(k)	Class II	Active
Prepowdered Vinyl Exam Gloves	K893334	FDA 510(k)	Class I	Active
Dynarex Sterile Lubricating Jelly	K092488	FDA 510(k)	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.