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Dynarex Corp.

US

Last updated September 17, 2026

Information

Country
US
Address
11 Dynarex Drive, Middletown, NY, 10941
Website
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LinkedIn
—
Facebook
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Email
—
Phone
—
PRRC Contact
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EUDAMED SRN
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FDA FEI Number
2431014
DUNS Number
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Catalogue (2572)

Page 49 of 52
DeviceModel / ReferenceRegistriesClassStatus
Sensi Wrap, Self-Adherent - Latex Free 4" x 5 yds White 3339
FDA UDI
Class IActive
Mini Scissors 4190
FDA UDI
Class IActive
EpiRite Syringes, Non-Toxic, 1mL, Luer Slip, Sterile 6985
FDA UDI
Class IIActive
Resp-O2 Oxygen Mask Non-Rebreather, Infant 33054
FDA UDI
Class IActive
Machine Bag 2162
FDA UDI
Class IActive
Replacement Mattress Cover for 10422 & 10429 10481
FDA UDI
Class IActive
ECG Snap Electrodes 7101
FDA UDI
Class IIActive
Resp-O2 Non-Rebreather Elongated Mask, Adult, With Safety Vent, 7'(2.1m) 33050U
FDA UDI
Class IActive
DynaCare Maxi Pads, Ultra Thin with Wings 1361
FDA UDI
Class IActive
Resp-O2 Nasopharyngeal Airway Kit, 6 NPA + 6 Packs of DynaLube 36270
FDA UDI
Class IActive
Abdominal Binder 4371
FDA UDI
Class IActive
Resp-O2 Non-Rebreather Elongated Mask, Pediatric, 7' (2.1m) Crush-Resistant 33053U
FDA UDI
Class IActive
Resp-O2 Intubating Stylette, 6FR 36265
FDA UDI
Class IActive
Resp-O2 Endotracheal Tube Introducer (Bougie), Pediatric, 10 FR 36260
FDA UDI
Class IActive
CurPro Silk Sutures Natural Material, Braided Black, Nonabsorbable 9143
FDA UDI
Class IIActive
Suction Canister 4670
FDA UDI
Class IIActive
Sensi-Wrap, Self Adherent 3296
FDA UDI
Class IActive
Universal Q-Bar, 1 Pair 12960
FDA UDI
Class IActive
Sensi Wrap, Self-Adherent - Latex Free 4" x 5 yds Kid Pack 3329
FDA UDI
Class IActive
Sensi-Wrap, Self Adherent 3277
FDA UDI
Class IActive
Elastic Bandages 3664
FDA UDI
Class IActive
Resp-O2 Oral Airway, Berman Type, 40 mm, Infant, Pink 36301
FDA UDI
Class IActive
Pediatric Compressor Nebulizer Pig 5608PG
FDA UDI
Class IIActive
Urethral Catheterization Tray 4925
FDA UDI
Class IIActive
CurPro Nylon Sutures, Black Monofilament, Nonabsorbable, Synthetic 9101
FDA UDI
Class IIActive
LabChoice Universal Pipette Tips, Without Filter, Neutral, Sterile, 100-1250ul 40163
FDA UDI
Class IActive
CuraFoam Foam Dressing 3013
FDA UDI
Class IActive
Endotracheal Tubes 4557
FDA UDI
Class IIActive
DynaRide Pediatric Wheelchair with Footrest 12" 15009-12DFR
FDA UDI
Class IActive
Resp-O2 Suction Catheter Kit 32092
FDA UDI
Class IActive
Closed Circuit Foley Catheter Tray - Sterile - 18 FR 5007
FDA UDI
Class IIActive
Footboard 12910-MH
FDA UDI
Class IIActive
SecureSafe Syringe With Safety Needle 8930
FDA UDI
Class IIActive
LabChoice Electronic Pipette, Eight Channel, Adjustable Volume, 30-300 uL 40112
FDA UDI
Class IActive
Impression Trays 2221
FDA UDI
Class IActive
Advantage Gauze Sponge- Sterile 3369
FDA UDI
Class IActive
Headboard 12902-CH
FDA UDI
Class IIActive
Instant Cold Pack with Urea (Non-Toxic) 4517
FDA UDI
Class IActive
Pen Needles 7027
FDA UDI
Class IIActive
Sensi-Wrap, Self Adherent 3282
FDA UDI
Class IActive
Resp-O2 Closed Suction Tracheostomy Catheters, Sterile 31012
FDA UDI
Class IActive
Dyna Safety Nitrile Exam Gloves, Powder Free, Blue, 2 pair, X-Large 2625
FDA UDI
Class IActive
Headboard 12901-MH
FDA UDI
Class IIActive
Ever-Soft Foam Cushion 10650
FDA UDI
Class IActive
Resp-O2 Small Volume Nebulizer 6 cc Cup 34121
FDA UDI
Class IIActive
Dynarex Bari + Max Bariatric Platform Attachment 10213
FDA UDI
Class IActive
Powder Coated Grab Bar 12" 10305
FDA UDI
Class IActive
Dynarex Protech Ultra Monitor P-800900
FDA UDI
Class IActive
LabChoice Transfer Pipettes, Large Bulb, Transparent, 5mL, Sterile 40205
FDA UDI
Class IActive
Insulin Syringe 6953
FDA UDI
Class IIActive

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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.

DateRecall No.ClassStatusReason
May 8, 2018Z-1955-2018—terminated

The device is equipped with a dial that has an inaccurate flow rate indicator.

Mar 3, 2016Z-2057-2016—terminated

Exterior carton is mis-labeled as Sterile. Non-sterile, bulk specimen containers were packed in incorrect exterior carton.

Jul 2, 2014Z-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, 2004Z-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, 2002Z-0573-03—terminated

Product labeled as 'latex free' but recent tests indicate that it contains minute amounts of latex.

Dec 31, 2002Z-0572-03—terminated

Product labeled as 'latex free' but recent tests indicate that it contains minute amounts of latex.