FDA Registration
Active
🇺🇸 United States
Prime Med Shop LLC
Reg #: 3013545943
·
FEI: 3013545943
·
Expires 2026
Products
28
Proprietary Names
12
Establishment Types
1
Classifications
28
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Registration Details
- Registration Name
- Prime Med Shop LLC
- Registration Number
- 3013545943
- FEI Number
- 3013545943
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 10749 Cash Road
- City
- Stafford
- State
- TX
- ZIP
- 77477
- Country
- US
Regulatory Submissions
- 510(k) Number
- K061471
Owner / Operator
- Firm Name
- Prime Med Shop LLC
- Operator Number
- 10054629
- Address
- 10749 Cash Road
- City
- Stafford
- State
- TX
- Postal Code
- 77477
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2018-06-29 |
| Oximeter, Infrared, Sporting, Aviation | OCH | Class 2 | Cardiovascular | No | 2017-04-10 |
| Test, Urine Leukocyte | LJX | Class 1 | Hematology | No | 2023-11-02 |
| Cushion, Flotation | KIC | Class 1 | Physical Medicine | No | 2017-09-22 |
| Adaptor, Hygiene | ILS | Class 1 | Physical Medicine | No | 2020-06-25 |
| Mattress, Air Flotation, Alternating Pressure | FNM | Class 2 | General Hospital | No | 2026-05-14 |
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | JIR | Class 1 | Clinical Chemistry | No | 2023-11-02 |
| Table, Mechanical | INW | Class 1 | Physical Medicine | No | 2021-07-13 |
| Adaptor, Dressing | ILD | Class 1 | Physical Medicine | No | 2017-09-22 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2022-02-02 |
| Aid, Transfer | IKX | Class 1 | Physical Medicine | No | 2026-05-14 |
| Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality | JMZ | Class 1 | Clinical Chemistry | No | 2023-11-02 |
| Dye-Indicator, Ph (Urinary, Non-Quantitative) | CEN | Class 1 | Clinical Chemistry | No | 2023-11-02 |
| Walker, Mechanical | ITJ | Class 1 | Physical Medicine | No | 2017-05-27 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2020-04-27 |
| Solution, Copper Sulfate For Specific Gravity Determinations | KSL | Class 1 | Hematology | No | 2023-11-03 |
| Mattress, Flotation Therapy, Non-Powered | IKY | Class 1 | General Hospital | No | 2017-09-24 |
| Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | CDM | Class 1 | Clinical Chemistry | No | 2023-11-02 |
| Cane, Safety Walk | KHY | Class 1 | Physical Medicine | No | 2022-07-12 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | Class 1 | Clinical Chemistry | No | 2023-11-02 |
| Adult Portable Bed Rails For Medical Purposes | QTC | Class 1 | Physical Medicine | No | 2025-04-22 |
| Accessories, Wheelchair | KNO | Class 1 | Physical Medicine | No | 2017-09-22 |
| Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | JJB | Class 1 | Clinical Chemistry | No | 2023-11-02 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | Class 1 | General, Plastic Surgery | No | 2021-07-29 |
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | JMT | Class 1 | Clinical Chemistry | No | 2023-11-02 |
| Exerciser, Non-Measuring For Stroke Rehabilitation | PKS | Class 1 | Physical Medicine | No | 2018-11-07 |
| Bed, Manual | FNJ | Class 1 | General Hospital | No | 2017-09-22 |
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 2017-09-22 |
Proprietary Names
Zacurate Digital Fingertip Pulse Oximeter for sports and aviation use only - For adults and children
Coccyx Cushion
Knee Pillow
Swivel Shower Stool
Raised Toilet Seat
Bath Tub Handle
Daily assist device, Sock aid
Eggcrate mattress pad
Folding Cane
Oxygen tank backpack
Bed assist rail
Lumbar back support pillow
Establishment Types
Complaint File Establishment per 21 CFR 820.198