Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3018940143

FEI Number

3018940143

Entity Name

OXILINE LLC

City/State/Country

Miami, FL, US

Establishment Address

140 NW 37th ST, Miami, FL 33127, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

OXILINE LLC (Owner Number: 10081725)

Owner / Operator Contact Address

140 NW 37th ST, Miami, FL 33127, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Pulse MD PRO Pulse Oximeter BM1000A; Pulse Oximeter BM2000A Electronic Blood Pressure Monitor Pressure X Pro Scale XS Pro Scale MD Pro Gluxo XS Pro System, test, blood glucose, over the counter Lancets Therma XS Pro Electrode, cutaneous Elite-X Pads Hear 9S Pro Hear XS Pro Tens XS PRO STIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER System measurement Pressure XS Mini Pulse XS Pro Pulse 9S Pro Oximeter TENS Q Pro

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2022-01-26
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2021-08-17
PUH	Analyzer, Body Composition, Exempt	Cardiovascular	Class 2	870.2770	2026-01-26
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2024-10-03
QRK	Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2026-01-26
QRL	Multiple Use Blood Lancet For Single Patient Use Only	General, Plastic Surgery	Class 2	878.4850	2026-01-26
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2026-01-26
QAQ	Adjunctive Predictive Cardiovascular Indicator	Cardiovascular	Class 2	870.2210	2026-01-26
DSB	Plethysmograph, Impedance	Cardiovascular	Class 2	870.2770	2026-01-26
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2026-01-26
MUD	Oximeter, Tissue Saturation	Cardiovascular	Class 2	870.2700	2026-01-26
DQR	Cannula, Catheter	Cardiovascular	Class 2	870.1300	2026-01-26
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2024-10-03
QUH	Self-Fitting Air-Conduction Hearing Aid, Over The Counter	Ear, Nose, Throat	Class 2	874.3325	2026-01-26
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2024-10-03
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2024-10-03
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2024-10-03
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2024-10-03
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2026-01-26

Official Correspondent

Juan Parra

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

OXILINE 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
K903523	Hewlett-Packard Co.	HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE	1990-10-23
K973147	Nellcor Puritan Bennett, Inc.	NPB-295 PULSE OXIMETER	1997-11-14
K231243	Guangdong Genial Technology Co., Ltd.	Finger Clip Pulse Oximeter	2023-10-31
K971628	Somanetics Corp.	SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS)	1997-10-10
K153184	Shenzhen Caremed Medical Technology Co., Ltd.	Caremed Reusable & Disposable SPO2 Sensors	2017-01-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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
Z-0023-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
Z-0028-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M, Part Number CS08653
Z-0029-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M W/PRINTER, Part Number CS08659

Similar Registrations

Registration Number	Establishment Name	Location
3014652024	CEA GROUP INTERNATIONAL CO.,LTD	Wenzhou Zhejiang, CN
1062836	DIGICARE BIOMEDICAL TECHNOLOGY, INC.	BOYNTON BEACH, FL, US
3013250653	MASIMO CORPORATION	Irvine, CA, US
3013418500	Quintana Supply, a division of Thomas Scientific	Haverhill, MA, US
9614470	RADIOMETER BASEL AG	BASEL Basel-Stadt, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018940143. Last updated year: 2026. Please use registration number 3018940143 when referencing this establishment in official correspondence.