FDA Registration
Active
🇺🇸 United States
ULINE, INC.
Reg #: 3002661124
·
FEI: 3002661124
·
Expires 2026
Products
13
Proprietary Names
0
Establishment Types
1
Classifications
13
Registration Details
- Registration Name
- ULINE, INC.
- Registration Number
- 3002661124
- FEI Number
- 3002661124
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 12575 Uline Dr
- City
- Pleasant Prairie
- State
- WI
- ZIP
- 53158
- Country
- US
Regulatory Submissions
- 510(k) Number
- K962188
Owner / Operator
- Firm Name
- Uline, Inc.
- Operator Number
- 10026543
- Address
- 12575 Uline Drive
- City
- Pleasant Prairie
- State
- WI
- Postal Code
- 53158
- Country
- US
- Correspondent
- Aisha Mendoza
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Latex Patient Examination Glove | LYY | Class 1 | General Hospital | No | 2013-11-14 |
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2016-11-23 |
| Protector, Hearing (Insert) | EWD | Class U | Unknown | No | 2018-11-14 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2020-11-19 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2019-10-17 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2019-10-14 |
| Protector, Hearing (Circumaural) | EWE | Class U | Unknown | No | 2018-11-14 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2025-04-23 |
| First Aid Kit With Drug | LRR | Class N | Unknown | No | 2018-11-09 |
| First Aid Kit Without Drug | OHO | Class 1 | General, Plastic Surgery | No | 2023-02-02 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2019-02-19 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2021-11-05 |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2024-01-26 |
Establishment Types
Repack or Relabel Medical Device