FDA Registration
Active
🇺🇸 United States
KEMP LLC
Reg #: 3005621729
·
FEI: 3005621729
·
Expires 2026
Products
17
Proprietary Names
16
Establishment Types
2
Classifications
17
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Registration Details
- Registration Name
- KEMP LLC
- Registration Number
- 3005621729
- FEI Number
- 3005621729
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 1900 Bancroft St
- City
- Charlotte
- State
- NC
- ZIP
- 28206
- Country
- US
Regulatory Submissions
- 510(k) Number
- K042727
Owner / Operator
- Firm Name
- KEMP LLC
- Operator Number
- 9084061
- Address
- 1900 Bancroft St
- City
- Charlotte
- State
- NC
- Postal Code
- 28206
- Country
- US
- Correspondent
- EDDIE - GULBENKIAN, III
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2025-03-13 |
| Valve, Non-Rebreathing | CBP | Class 2 | Anesthesiology | No | 2016-09-23 |
| Stretcher, Patient Restraint | NZD | Class 1 | General Hospital | No | 2025-02-05 |
| Ventilator, Emergency, Manual (Resuscitator) | BTM | Class 2 | Anesthesiology | No | 2025-02-05 |
| Oximeter, Infrared, Sporting, Aviation | OCH | Class 2 | Cardiovascular | No | 2025-01-21 |
| Tourniquet, Pneumatic | KCY | Class 1 | General, Plastic Surgery | No | 2025-03-11 |
| Pack, Hot Or Cold, Disposable | IMD | Class 1 | Physical Medicine | No | 2025-03-13 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2025-03-11 |
| Mask, Oxygen, Non-Rebreathing | KGB | Class 1 | Anesthesiology | No | 2024-11-26 |
| First Aid Kit Without Drug | OHO | Class 1 | General, Plastic Surgery | No | 2025-02-05 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2025-02-05 |
| Respirator, Surgical | MSH | Class 2 | General, Plastic Surgery | No | 2020-03-25 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2025-03-11 |
| Cylinder, Compressed Gas, And Valve | ECX | Class 1 | Anesthesiology | No | 2025-03-13 |
| Orthosis, Cervical | IQK | Class 1 | Physical Medicine | No | 2025-02-05 |
| Automated External Defibrillators (Non-Wearable) | MKJ | Class 3 | Cardiovascular | No | 2025-02-05 |
| Stretcher, Hand-Carried | FPP | Class 1 | General Hospital | No | 2025-02-05 |
Proprietary Names
Finger Splint, Hand Splint
Kemp USA
Head Immobilizer
Ambu BVM
Kemp USA Fingertip Pulse Oximeter
Tourniquets
Cold & Hot Pack For First Aid, Disposable
Adhesive Tapes and Bandages For First Aid
Kemp USA RapidSeal® CPR Mask
First Aid Kits (No Drugs)
Emerald Nitrile Gloves
Dressing, wound, hydrogel without drug and/or biologic
C Oxygen Tank, D Oxygen Tank, Oxygen Tank Valve Regulator
Cervical Extrication Collars
Philips AEDs
Kemp USA Spineboard
Establishment Types
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility