Is this your brand? Sign in to claim ownership.

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 11 of 52

Device	Model / Reference	Registries	Class	Status
Gastrostomy Tube, 3 port, 22fr, ENFit	5116	FDA UDI	Class II	Active
Panty Liner	1336	FDA UDI	Class I	Active
Non-Adherent Pads, Sterile	3438	FDA UDI	Class I	Active
CSR Wraps	4415	FDA UDI	Class II	Active
Footboard	12911-OA	FDA UDI	Class II	Active
Gastrostomy Tube, 3 port, 18fr, NON-ENfit	5121	FDA UDI	Class II	Active
Air-Water Syringe Tip	2232	FDA UDI	Class I	Active
Raised Toilet Seat without Arms	10361	FDA UDI	Class I	Active
Rotating Flange With Textured Grip Knurled Grab Bar 12"	10311	FDA UDI	Class I	Active
Vaginal Speculum	4915	FDA UDI	Class II	Active
Next Generation Stretch Vinyl Exam Gloves	6824	FDA UDI	Class I	Active
DynaSafety Waterproof Adhesive Tape 1/2" x 5yds	3653	FDA UDI	Class I	Active
Sensi-Wrap, Self Adherent	3279	FDA UDI	Class I	Active
Sensi Wrap, Self-Adherent - Latex Free 2" x 5 yds Purple	3314	FDA UDI	Class I	Active
LabChoice Culture Tubes, With Dual Position Cap, Polystyrene, Peel Pack, 12 x 75 mm	42301	FDA UDI	Class I	Active
Sensi-Wrap, Self Adherent	3284	FDA UDI	Class I	Active
DynaSorb Super Absorbent Dressing, Non-Adherent	3088	FDA UDI	Class I	Active
Durma+ DynaGinate AG, Calcium Alginate Dressing, 4" x 4"	3010	FDA UDI	U	Active
My Resp-O2 Penguin Compressor Nebulizer	34405	FDA UDI	Class II	Active
Hippo Pediatric Nebulizer	5607	FDA UDI	Class II	Active
Oral Airways, Disposable	4725	FDA UDI	Class I	Active
Full Body Sling w/Commode Opening, Mesh Medium	10742MD	FDA UDI	Class I	Active
Cervical Collar	4363	FDA UDI	Class I	Active
LabChoice Specimen Bags with Pouch, 4" x 6", 1.8 MIL	8023	FDA UDI	Class I	Active
Dynarex Bari + Max Bariatric HD Composit Swing Down Rail	12954	FDA UDI	Class I	Active
Resp-O2 Laryngeal Mask Airways Silicone, Non-Reinforced, Size 5.0 mm	36299	FDA UDI	Class I	Active
CSR Wraps	4436	FDA UDI	Class II	Active
Ever-Soft Pommel Gel Foam Cushion	10686	FDA UDI	Class I	Active
Deluxe Head Immobilizer	5628	FDA UDI	Class I	Active
SiliGentle AG Silver Silicone Foam Dressing	3086	FDA UDI	U	Active
LabChoice Midstream Specimen Catch Kit, Sterile	43028	FDA UDI	Class I	Active
Resp-O2 Venturi Select A Vent Elongated Adult Mask w/ 6 Dilutors	33070	FDA UDI	Class I	Active
Gait Belt	4354	FDA UDI	Class I	Active
DynaSafety Sheer Plastic Adhesive Bandages Sterile with Non-Stick Pad	3602-50	FDA UDI	Class I	Active
Syringes Without Needle, Non-Toxic, 3 ML, Luer Luck	6988	FDA UDI	Class II	Active
Nebulizer Kit	5603	FDA UDI	Class II	Active
Disposable ECG Snap Electrodes, With Pre-Gelled AG/AGCI Sensor	7102	FDA UDI	Class II	Active
Elongated Folding Bedside Commode	10373	FDA UDI	Class I	Active
Surgical Gauze Sponge	3233	FDA UDI	Class I	Active
Syringe w/Needle, Non-Toxic, Luer Lock, 5 ML, 20G x 1"	7004	FDA UDI	Class II	Active
Resp-O2 Small Volume Nebulizer 6 cc Cup	34102	FDA UDI	Class II	Active
Exam Gown, 3 ply	8101	FDA UDI	Class I	Active
Resp-O2 Endotracheal Tube With Stylette Cuffed, 6.5 mm	36250	FDA UDI	Class II	Active
Polypropylene Sutures	9117	FDA UDI	Class II	Active
Dynarex Bari + Max Bariatric HD Airfloat Air Mattress with Pump	10439	FDA UDI	Class II	Active
Resp-O2 Oxygen Supply Tubing	33207	FDA UDI	Class I	Active
Resp-O2 Suction Catheter Kit 8 FR Mini-Tray	32080	FDA UDI	Class I	Active
Dressing Change Tray, Sterile	4705	FDA UDI	Class I	Active
DynaSafety Absorbent Gauze Compress, 18" x 36" # 2	3200UB-2	FDA UDI	Class I	Active
10476 - Headboard/Footboard, Long Term Care beds, Amber Cherry, 1pr/Cs	10476	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.