Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012302888

FEI Number

3012302888

Entity Name

QUIPMENT INC.

City/State/Country

Kennesaw, GA, US

Establishment Address

1640 Airport Road, Suite 105, Kennesaw, GA 30144, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Quipment Inc (Owner Number: 10062070)

Owner / Operator Contact Address

1640 Airport Rd NW Suite 105, Kennesaw, GA 30144, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K182041

PMA Number

N/A

All Registered Proprietary Names

Cardioline H12+ Blood and Infusion Warmer Infusion Pump B. Braun Study Watch Catheter Endoflip Vented Vial Adapter 20mm BBraun Scale 874 Quipment MIR Dexcom G7 Pigtail Catheter seca 213 Exophthalmometer GSI Pello Microlife USA, Inc. Quipment 50mL Conical Centrifuge Tubes Falcon Corning, 352070 (Pack of 25) CABINET, INSTRUMENT, AC-POWERED, OPHTHALMIC ABPM Oscar II Ear Thermometer Welch Allyn Mortara MICROLAB SPIROMETER Dynamometer Echo Muscle Tester Hand-Held Dynamometer w/ Digital Screen Jamar Technologies, Jamar Plus+ / PN# 563213 M12R Holter Recorder Syringe BD Dexcom G6 Continuous Glucose Monitoring (CGM) System RECORDER, PAPER CHART Endoflip Catheter Dexcom G7 Welch Allyn, Inc. MIKRO 220; MIKRO 220R; UNIVERSAL 320; UNIVERSAL 320R Easy-on-pc WatchPat300 Dexcom G6

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2025-03-11
LGZ	Warmer, Thermal, Infusion Fluid	General Hospital	Class 2	880.5725	2024-04-30
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2024-05-13
DXH	Transmitters And Receivers, Electrocardiograph, Telephone	Cardiovascular	Class 2	870.2920	2026-05-12
FFX	System, Gastrointestinal Motility (Electrical)	Gastroenterology, Urology	Class 2	876.1725	2024-04-10
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2026-06-19
MEA	Pump, Infusion, Pca	General Hospital	Class 2	880.5725	2024-03-04
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2024-03-04
FRI	Scale, Stand-On, Patient	General Hospital	Class 1	880.2700	2026-04-08
GJS	Test, Time, Prothrombin	Hematology	Class 2	864.7750	2023-10-12
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2024-02-01
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2024-02-01
QBJ	Integrated Continuous Glucose Monitoring System, Factory Calibrated	Clinical Chemistry	Class 2	862.1355	2026-02-11
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2026-02-11
GCB	Needle, Catheter	General, Plastic Surgery	Class 1	878.4200	2025-03-26
FRW	Scale, Patient	General Hospital	Class 1	880.2720	2025-06-27
HLS	Exophthalmometer	Ophthalmic	Class 1	886.1270	2026-02-18
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	2025-05-09
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2024-01-12
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2024-03-04
LZH	Pump, Infusion, Enteral	General Hospital	Class 2	880.5725	2024-03-04
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2025-07-25
HRE	Cabinet, Instrument, Ac-Powered, Ophthalmic	Ophthalmic	Class 1	886.1860	2024-08-20
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2024-12-24
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2025-11-26
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2023-08-10
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2026-03-04
HRW	Dynamometer, Nonpowered	Orthopedic	Class 1	888.1250	2024-05-02
MLO	Electrocardiograph, Ambulatory, With Analysis Algorithm	Cardiovascular	Class 2	870.2800	2024-12-02
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2025-09-12
QBJ	Integrated Continuous Glucose Monitoring System, Factory Calibrated	Clinical Chemistry	Class 2	862.1355	2024-07-03
DSF	Recorder, Paper Chart	Cardiovascular	Class 1	870.2810	2024-04-11
FFX	System, Gastrointestinal Motility (Electrical)	Gastroenterology, Urology	Class 2	876.1725	2025-12-03
QBJ	Integrated Continuous Glucose Monitoring System, Factory Calibrated	Clinical Chemistry	Class 2	862.1355	2025-04-04
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2024-02-09
GKG	Centrifuge, Hematocrit	Hematology	Class 2	864.6400	2024-01-11
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2025-11-26
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2026-06-03
QDK	Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management	Clinical Chemistry	Class 2	862.1355	2025-04-02

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Quipment Inc

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
K131913	Philips Medizin Systeme Boeblingen GmbH	INTELLIVUE CL SPO2 POD AND CL NBP POD, PHILIPS INTELLIVUE PATIENT MONITORS MP5, MP5T, MP5SC	2013-11-26
K913718	Abbott Laboratories	PANCRETEC I.V. MODEL 5000 INFUS DEVICE, MODIFIED	1991-10-30
K840616	Advanced Bio Systems, Inc.	MINI-PUMP U-100	1984-03-30
K850183	Deltec Systems, Inc.	CADD-VT, 5300 AMBULATORY INFUSION PUMP W/3050, 50M	1985-03-13
K820986	Dart Medical Equipment	EKG MONITORS, VARIOUS MODELS	1982-04-29

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2011	Baxter Healthcare Corp. Rt.	2	Baxter Colleague Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Codes: 2M8151, 2M8161, and 2M9161.
Z-0002-2011	Baxter Healthcare Corp. Rt.	2	Baxter Colleague Triple Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product codes: 2M8153, and 2M8163.
Z-0005-2025	Zyno Medical LLC	2	Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64z
Z-0006-2011	CareFusion Corporation	2	CareFusion Alaris PC Unit Model 8015 (formerly Medley PC Unit): Alaris PC Units (Model 8015) with logic board part number TC10005522 manufactured and serviced between December 20, 2008 and May 6, 2009; and Alaris PC Units (with logic board part number TC10005572 manufactured and serviced between May 7, 2009 and September 8, 2009. For use with Alaris infusion and monitoring systems.
Z-0007-2012	B Braun Medical, Inc	2	Outlook ES Safety Infusion System, Model 621-100ES, 621-200ES, 621-300ES, and 621-400ES B. Braun Medical Inc., 1601 Wallace Drive, Suite 150, Carrollton, TX 75006 The Outlook ES pump is intended for use with B. Braun Medical Inc., Horizon Pump IV Sets to regulate the flow of primary and secondary fluids when positive pressure is required.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012302888. Last updated year: 2026. Please use registration number 3012302888 when referencing this establishment in official correspondence.