Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2649614

FEI Number

2649614

Entity Name

Baxter Healthcare of Puerto Rico LLC

City/State/Country

AIBONITO, PR, US

Establishment Address

RD. 721, KM. 0.3, AIBONITO, PR 00705, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BAXTER HEALTHCARE CORPORATION (Owner Number: 1417572)

Owner / Operator Contact Address

One Baxter Parkway, Deerfield, IL 60015, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K921899

PMA Number

N/A

All Registered Proprietary Names

Interlink System T Connector Ext Se Continu-Flo Interlink Interlink Universal Vial Adapter Clearlink Interlink None None The Mill Disposable - Fine The Mill Disposable - Medium None None None None Duo-Vent Continu-Flo Interlink None None None None AutoPlex w/o Needle Int. PCD, 11G Needle 100mm Femoral Nozzle High Vac. Mix Bowl Revolution Cancellous Nozzle w/Press Kit Femoral Nozzle High Vac.Mix.Bowl with Femoral Nozzle 180 gr. Cartridge With Femoral Nozzle Revolution 65 Posterior Femoral Press Nozzle Revolution CMS w/ Femoral Breakaway Nozzle Revolution Humeral Nozzle 180 gr. Cartridge Small Prox. Press (W/O Hub) PCD, W/O Needle 65 deg. Post. Fem. Press None Strykeflow 2 with Tip Strykeflow Disposable S/I Tip None Solution Sets w/Capless Luer Valve Duo-Vent Clearlink Control-A-Flo Continu-Flo Buretrol Interlink None OptaBlate 11G Hand Drill Pack None None None Duo-Vent Clearlink Interlink Clearlink Luer Activated Valve Neutral Luer Activated Device (One-Link Needle-free IV Connector) and Extension Sets with One-Link Needle-free IV Connec One-Link Knotilus+ None Dual Luer Lock Cap None Aviva Viaflex Additive Cap None StrykeFlow II with Connected Tubing Strykeflow Single Spike Tube Set StrykeFlow PS StrykeFlow II 10" Suction Irrigator Interlink System T-Connector ExtSet Interlink

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2007-12-04
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2007-12-03
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2015-11-24
EQJ	Bur, Ear, Nose And Throat	Ear, Nose, Throat	Class 1	874.4140	2015-11-24
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2012-11-28
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2015-11-24
OAR	Injector, Vertebroplasty (Does Not Contain Cement)	Orthopedic	Class 1	888.4200	2015-11-24
LZN	Cement Obturator	General, Plastic Surgery	Class 2	878.3300	2015-11-24
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2015-11-24
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2015-11-24
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2009-08-10
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2015-11-24
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2015-11-24
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2015-11-24
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2015-11-24
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2015-11-24
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2015-11-24
JDZ	Mixer, Cement, For Clinical Use	Orthopedic	Class 1	888.4210	2012-11-28
GFF	Bur, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4820	2015-11-24
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2012-11-28
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2022-11-15
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2007-12-03
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2007-12-03
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	1990-01-03
OCJ	Spinal Channeling Instrument, Vertebroplasty	Orthopedic	Class 1	888.4540	2023-11-28
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2015-11-24
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	1988-12-01
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2015-11-24
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2011-10-28
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2013-12-20
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-12-04
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-12-04
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2015-11-24
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2011-02-15
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2015-11-24
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2015-11-24
KPE	Container, I.V.	General Hospital	Class 2	880.5025	2011-07-14
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2022-11-15
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2012-11-28
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2007-12-03

Official Correspondent

Maha Nolasco

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BAXTER HEALTHCARE CORPORATION

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3014226707	BARDY DIAGNOSTICS, INC.	Bellevue, WA, US
3019257308	VIDEOMED SRL	LIMENA Padova, IT
1314492	Baxter Healthcare Corporation	MEDINA, NY, US
3007143268	Baxter Medical Systems GmbH + Co. KG	SAALFELD Thuringia, DE
8010130	BAXTER SA	LESSINES Hainaut, BE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03
K953474	Medikmark, Inc.	IV START KIT	1995-10-02
K972493	Nipro Medical Corp.	NIPRO DISPOSABLE SOLUTION INFUSION SET	1997-09-18
K982672	Baxter Healthcare Corp	COLLEAGUE PUMP SYRINGE ADAPTER SET	1998-09-04
K143446	Roche Diagnostics GmbH	Accu-Chek FlexLink Plus infusion set	2015-08-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
Z-0013-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device; Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2649614. Last updated year: 2026. Please use registration number 2649614 when referencing this establishment in official correspondence.