FDA Registration
Active
🇺🇸 United States
DYNAREX CORP.
Reg #: 2431014
·
FEI: 2431014
·
Expires 2026
Products
5
Proprietary Names
19
Establishment Types
1
Classifications
5
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Registration Details
- Registration Name
- DYNAREX CORP.
- Registration Number
- 2431014
- FEI Number
- 2431014
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 11 Dynarex Drive
- City
- Middletown
- State
- NY
- ZIP
- 10941
- Country
- US
Regulatory Submissions
- 510(k) Number
- K152970
Owner / Operator
- Firm Name
- DYNAREX CORP.
- Operator Number
- 2431014
- Address
- 155 Chestnut Ridge Rd, --
- City
- Montvale
- State
- NJ
- Postal Code
- 07645
- Country
- US
- Correspondent
- Daniel M Consaga
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2016-11-17 |
| Valve, Non-Rebreathing | CBP | Class 2 | Anesthesiology | No | 2007-12-19 |
| Tubes, Gastrointestinal (And Accessories) | KNT | Class 2 | Gastroenterology, Urology | No | 2009-01-13 |
| Cup, Eye | LXQ | Class U | Unknown | No | 2015-09-03 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2008-09-15 |
Proprietary Names
Dynarex Xeroform Petrolatum Dressing
CPR Shield
3403 - Packing Strips Plain, Sterile, 1"¿ x 5 yds, 12/Cs
3401 - Packing Strips Plain, Sterile, 1/4"¿ x 5 yds, 12/Cs
3413 - Packing Strips Iodoform, Sterile, 1" x 5 yds, 12/Cs
3412 - Packing Strips Iodoform, Sterile, 1/2"¿ x 5 yds, 12/Cs
3411 - Packing Strips Iodoform, Sterile, 1/4"¿ x 5 yds, 12/Cs
3402 - Packing Strips Plain, Sterile, 1/2"¿ x 5 yds, 12/Cs
3404 - Packing Strips Plain, Sterile, 2"¿ x 5 yds, 12/Cs
3414 - Packing Strips Iodoform, Sterile, 2"¿ x 5 yds, 12/Cs
4280 - Enteral Feeding Gravity Bag Set w/Enfit Connector, 30/Cs
4275 - Enteral Delivery Pump Bag Set w/Enfit Connector, 30/Cs
4274 - DynaSpike Enteral Delivery Pump Set w/Enfit Connector
4277 - Enteral Delivery Gravity Bag Set, 30/Cs
4278 - Enteral Delivery Pump Spike Set, 30/Cs
4279 - Enteral Delivery Pump Screw Spike Set, 30/Cs
4276 - Enteral Delivery Pump Bag Set, 30/Cs
3380 - Eye Cups, Non-Sterile, 50/6/Cs
True Advantage Nitrile Exam Gloves
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility