Prime Med Shop LLC

FDA Device Registration & Listing · Stafford, TX, US · Registration 3013545943

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3013545943
FEI Number
3013545943
Entity Name
Prime Med Shop LLC
City/State/Country
Stafford, TX, US
Establishment Address
10749 Cash Road, Stafford, TX 77477, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Prime Med Shop LLC (Owner Number: 10054629)
Owner / Operator Contact Address
10749 Cash Road, Stafford, TX 77477, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K191829
PMA Number
N/A

All Registered 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2018-06-29
OCH Oximeter, Infrared, Sporting, Aviation Cardiovascular Class 2 870.2700 2017-04-10
LJX Test, Urine Leukocyte Hematology Class 1 864.7675 2023-11-02
KIC Cushion, Flotation Physical Medicine Class 1 890.3175 2017-09-22
ILS Adaptor, Hygiene Physical Medicine Class 1 890.5050 2020-06-25
FNM Mattress, Air Flotation, Alternating Pressure General Hospital Class 2 880.5550 2026-05-14
JIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1645 2023-11-02
INW Table, Mechanical Physical Medicine Class 1 890.3750 2021-07-13
ILD Adaptor, Dressing Physical Medicine Class 1 890.5050 2017-09-22
DQA Oximeter Cardiovascular Class 2 870.2700 2022-02-02
IKX Aid, Transfer Physical Medicine Class 1 890.5050 2026-05-14
JMZ Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality Clinical Chemistry Class 1 862.1540 2023-11-02
CEN Dye-Indicator, Ph (Urinary, Non-Quantitative) Clinical Chemistry Class 1 862.1550 2023-11-02
ITJ Walker, Mechanical Physical Medicine Class 1 890.3825 2017-05-27
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2020-04-27
KSL Solution, Copper Sulfate For Specific Gravity Determinations Hematology Class 1 864.9320 2023-11-03
IKY Mattress, Flotation Therapy, Non-Powered General Hospital Class 1 880.5150 2017-09-24
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2023-01-01
CDM Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1785 2023-11-02
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2023-01-01
KHY Cane, Safety Walk Physical Medicine Class 1 890.3075 2022-07-12
JIN Nitroprusside, Ketones (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1435 2023-11-02
QTC Adult Portable Bed Rails For Medical Purposes Physical Medicine Class 1 890.5050 2025-04-22
KNO Accessories, Wheelchair Physical Medicine Class 1 890.3910 2017-09-22
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2023-01-01

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Prime Med Shop LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K100940 Andon Health Co, Ltd. FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965 2010-06-29
K251581 Shenzhen Hingmed Medical Instrument Co., Ltd. Wearable Ambulatory Blood Pressure Monitor (WBP-02A) 2026-02-13
K200521 Health & Life Co., Ltd. Full Automatic(NIBP) Blood Pressure Monitor 2020-06-12
K152003 Andon Health Co, Ltd. iHealth BP3L Wireless Blood Pressure Monitor 2015-09-24
K952827 Sein Electronics Co., Ltd. FULL AUTO WRIST BLOOD PRESSURE METER MODEL SE-5000 1996-11-14

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0032-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.
Z-0020-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013545943. Last updated year: 2026. Please use registration number 3013545943 when referencing this establishment in official correspondence.
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