FDA Registration
Active
🇺🇸 United States
UNITE MEDICAL, LLC
Reg #: 3015727296
·
FEI: 3015727296
·
Expires 2026
Products
23
Proprietary Names
19
Establishment Types
2
Classifications
23
Registration Details
- Registration Name
- UNITE MEDICAL, LLC
- Registration Number
- 3015727296
- FEI Number
- 3015727296
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 1487 Trae Lane
- City
- Lithia Springs
- State
- GA
- ZIP
- 30122
- Country
- US
Regulatory Submissions
- 510(k) Number
- K202842
Owner / Operator
- Firm Name
- Unite Medical, LLC
- Operator Number
- 10061044
- Address
- 1487 Trae Lane
- City
- Lithia Springs
- State
- GA
- Postal Code
- 30122
- Country
- US
- Correspondent
- Richard Reed
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2023-12-13 |
| Mask, Scavenging | KHA | Class 1 | Anesthesiology | No | 2020-08-13 |
| Adaptor, Hygiene | ILS | Class 1 | Physical Medicine | No | 2026-02-16 |
| Joint, Shoulder, External Limb Component | IQQ | Class 1 | Physical Medicine | No | 2019-12-20 |
| Bag, Ice | KYR | Class 1 | General Hospital | No | 2024-06-20 |
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 2019-12-20 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2024-01-19 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2024-01-19 |
| Crutch | IPR | Class 1 | Physical Medicine | No | 2026-02-16 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2019-12-20 |
| Respirator, Surgical | MSH | Class 2 | General, Plastic Surgery | No | 2020-08-13 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2019-12-20 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2025-03-10 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-08-13 |
| Orthosis, Cervical | IQK | Class 1 | Physical Medicine | No | 2019-12-20 |
| Pack, Hot Or Cold, Water Circulating | ILO | Class 2 | Physical Medicine | No | 2025-11-20 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2025-05-28 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2025-05-28 |
| Joint, Elbow, External Limb Component, Mechanical | IRD | Class 1 | Physical Medicine | No | 2019-12-20 |
| Unit, Wrist, External Limb Component, Mechanical | ISZ | Class 1 | Physical Medicine | No | 2019-12-20 |
| Walker, Mechanical | ITJ | Class 1 | Physical Medicine | No | 2026-02-15 |
| Joint, Hip, External Brace | ITS | Class 1 | Physical Medicine | No | 2019-12-20 |
| Exerciser, Non-Measuring | ION | Class 1 | Physical Medicine | No | 2026-02-16 |
Proprietary Names
medava® 3-Ply Surgical Mask
Mask
Portable commode chair, Toilet safety frame
Unite Medical
Unite Medical® Cryo Ice Pack
medava® SoftTouch CHEMO RATED Nitrile Examination Gloves
Adjustable Offset Walking Cane with Foam Handle
Respirator
medava® SoftTouch Nitrile Powder Free Examination Gloves Tested for Use w/ Chemotherapy Drugs and Fentanyl, (Blue)
Gown;Mask
medava® 4-Ply Surgical Mask
RegeniCool Pro Cold Compression Therapy System, Total Joint Specialists
medava® Procedure Mask with Ear Loops and Surgical Mask with Ties
medava® Patient Nitrile Examination Gloves, Powder Free, Tested for Use w/Chemotherapy Drug
medava® Blue Powder-Free Nitrile Exam Gloves, Tested For Use W/Chemotherapy Drug
Sterile Hypodermic needle for Single use; Sterile Hypodermic Syringe for Single use, with/without needle; luer/luer-lock
Sterile Hypodermic Syringe for Single use, with/without needle; luer/luer- lock
Folding Walker with Front Wheels, Wide Folding Walker with Adjustable Width
Portable Pedal Exerciser with LCD Display, Hamstring and Lower Body Stretching Device, Knee Rehabilitation Glider
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility