Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3020460367

FEI Number

3020460367

Entity Name

BOUND TREE MEDICAL, LLC

City/State/Country

Grand Prairie, TX, US

Establishment Address

2911 S GREAT SW PARKWAY, SUITE 200B, Grand Prairie, TX 75052, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BEMS Holdings, LLC (Owner Number: 9003409)

Owner / Operator Contact Address

5000 BRADENTON AVE, --, Dublin, OH 43017, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Blood Collection Module, Intermediate - 680152-KIT AIRWAY KIT GUEDEL SIZES 0-5 - SEEGAK Curaplex Air-Q sp3G BLS Kit Size 4 with Suction Cath, Connector, ET Tube Holder, and Lube Jelly - 670275-KIT Curaplex Air-Q sp3G Kit Size 4 with NG Tube and Lube Jelly - 670281-KIT Field Blood Transfusion Kit - 1715-01827

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAN	Regulator, Pressure, Gas Cylinder	Anesthesiology	Class 1	868.2700	2014-05-13
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2014-05-13
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2017-01-30
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2019-07-30
BYE	Attachment, Breathing, Positive End Expiratory Pressure	Anesthesiology	Class 2	868.5965	2017-01-30
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2022-06-21
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2014-05-15
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2017-01-30
BTL	Ventilator, Emergency, Powered (Resuscitator)	Anesthesiology	Class 2	868.5925	2017-01-30
OFO	Airway Suction Kit	Anesthesiology	Class 1	868.6810	2018-01-03
OFZ	Blood Specimen Collection Kit (Excludes Hiv Testing)	Anesthesiology	Class 1	868.1100	2019-12-10
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2019-08-22
OGP	Cricothyrotomy Kit	Anesthesiology	Class 2	868.5800	2014-05-15
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2019-07-30
OEV	Cardiopulmonary Resuscitation Aid Kit	Anesthesiology	Class 2	868.5915	2017-01-30
OKH	Body Fluids Barrier Kit	General, Plastic Surgery	Class 2	878.4040	2017-01-30
OGL	Oxygen Administration Kit	Anesthesiology	Class 2	868.5655	2015-12-29
BZE	Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer	Anesthesiology	Class 2	868.5270	2020-02-03
OJS	Tourniquet Kit	General, Plastic Surgery	Class 1	878.5900	2014-05-15
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2017-01-30
PQX	Epinephrine Syringe	General Hospital	Class 2	880.5860	2019-07-30
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2017-01-30
MCY	Wound Dressing Kit	General Hospital	Class 2	880.5075	2015-12-14
LNZ	Changer, Tube, Endotracheal	Anesthesiology	Class 2	868.5730	2017-01-30
CFW	Copper Reduction, Glucose	Clinical Chemistry	Class 2	862.1345	2017-01-30
PXG	Spill Kit	General Hospital	Class 1	880.6890	2017-11-28
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2017-01-30
FNY	Basin, Emesis	General Hospital	Class 1	880.6730	2018-01-03
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2019-07-30
OKU	Emergency Obstetrical Kit	Obstetrics/Gynecology	Class 1	884.4520	2014-05-15
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2019-07-30
BTQ	Airway, Nasopharyngeal	Anesthesiology	Class 1	868.5100	2014-05-13
CCT	Applicator (Laryngo-Tracheal), Topical Anesthesia	Anesthesiology	Class 2	868.5170	2017-01-30
MRZ	Accessories, Pump, Infusion	General Hospital	Class 2	880.5725	2017-01-30
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2005-09-21
PXQ	Burn Dressing Tray	General, Plastic Surgery	Class 1	878.4022	2019-07-30
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2017-01-30
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2022-06-22
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2017-01-30
NGT	Saline, Vascular Access Flush	General Hospital	Class 2	880.5200	2023-01-04
NZD	Stretcher, Patient Restraint	General Hospital	Class 1	880.6900	2019-07-30
POQ	Blood Transfusion Kit	General Hospital	Class 2	880.5440	2017-01-30
KSZ	System, Test, Automated Blood Grouping And Antibody	Hematology	Class 2	864.9175	2019-07-30
CBT	Arterial Blood Sampling Kit	Anesthesiology	Class 1	868.1100	2019-08-01
PAD	Chest Drainage Kit	General Hospital	Class 2	880.6740	2019-07-30
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2024-07-01
CBP	Valve, Non-Rebreathing	Anesthesiology	Class 2	868.5870	2017-01-30
OGH	Laryngoscope Kit	Anesthesiology	Class 1	868.5540	2014-05-15
BWF	Spirometer, Therapeutic (Incentive)	Anesthesiology	Class 2	868.5690	2022-06-22
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2018-01-03
FPO	Stretcher, Wheeled	General Hospital	Class 2	880.6910	2019-08-22
OKE	Port Introducer Kit	General Hospital	Class 2	880.5965	2017-01-30
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2017-01-30
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2019-07-30

Official Correspondent

DARRELL HUGHES

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BEMS Holdings, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3014680755	SARNOVA HC, LLC	Dublin, OH, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K943349	Quinton, Inc.	MAHURKAR DUAL LUMEN CATHETER	1995-03-22
K912158	Medical Device Inspection Co., Inc.	CENTRAL VENOUS CATHETER DRESSING CHANGE TRAY	1991-10-23
K792722	Novametrix Medical Systems, Inc.	NOVAMETRIX CPAP NASAL CANNULA	1980-01-24
K082979	Resmed, Ltd.	S8 ADVANCE	2009-01-02
K203126	Resmed Pty , Ltd.	S10 Kirra	2020-12-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0037-2010	Airgas Puritan Medical Puritan Medical Unit	1	AGI-2237 Portable 2 Cylinder Manifold Cart, for connecting medical gas cylinders.
Z-0038-2010	Airgas Puritan Medical Puritan Medical Unit	1	AGI-2238 Portable 4 Cylinder Manifold Cart, for connecting medical gas cylinders.
Z-0002-2024	ARROW INTERNATIONAL Inc.	2	Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0003-2024	ARROW INTERNATIONAL Inc.	2	Arrow Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0009-2023	B Braun Medical Inc	2	Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3020460367. Last updated year: 2026. Please use registration number 3020460367 when referencing this establishment in official correspondence.