Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008998256

FEI Number

3008998256

Entity Name

BIOMERICS

City/State/Country

Salt Lake City, UT, US

Establishment Address

6030 W Harold Gatty Drive, Salt Lake City, UT 84116, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Biomerics (Owner Number: 10042380)

Owner / Operator Contact Address

6030 W Harold Gatty Drive, Salt Lake City, UT 84116, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PeriCross Epicardial Access Kit Nimbus Electrosurgical Radiofrequency Multitined Expandable Electrode Peripheral Cannulae Crosser iQ CTO Recanalization System Arterial Cannulae Intra-Aortic Occlusion Catheter (IntraClude) Arterial Cannulae (EndoReturn) Disposable-Tissue Retractor Pristine Long-Term Hemodialysis Catheter Trabex+ Trabex Disposable-Knot Pusher Vesta Uretero 1 Video Ureteroscope System Arterial Cannulae BD Intraosseous Vascular Access System LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR) BD Intraosseous Infusion System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2025-09-18
GXI	Probe, Radiofrequency Lesion	Neurology	Class 2	882.4725	2012-11-21
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2020-11-20
PDU	Catheter For Crossing Total Occlusions	Cardiovascular	Class 2	870.1250	2023-12-27
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2020-11-20
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2020-11-20
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2020-11-20
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2020-11-20
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2021-04-06
HNN	Knife, Ophthalmic	Ophthalmic	Class 1	886.4350	2020-12-15
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2020-11-20
GXI	Probe, Radiofrequency Lesion	Neurology	Class 2	882.4725	2020-05-15
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2024-04-29
DQR	Cannula, Catheter	Cardiovascular	Class 2	870.1300	2020-11-20
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2019-11-26
KDN	System, Perfusion, Kidney	Gastroenterology, Urology	Class 2	876.5880	2016-02-09
MHC	Needle, Interosseous	General Hospital	Class 2	880.5570	2021-03-09

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Biomerics

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3016079756	Biomerics NLE	Monroe, CT, US
3026390991	Biomerics Dominican Republic	Haina San Cristobal, DO
3014246639	Biomerics Cartago	Cartago, CR
3012159165	BIOMERICS Advanced Catheter	Brooklyn Park, MN, US
3003678543	Biomerics Alajuela	ALAJUELA, CR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K101883	St Jude Medical	6F ENGAGE/ENGAGE TR INTRODUCER	2010-09-07
K034025	Nmt Medical, Inc.	NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC	2004-03-26
K122854	Arrow International (Subsidiary of Teleflex Inc.)	ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER	2013-01-04
K233691	Acutus Medical, Inc.	FlexCath Cross Transseptal Solution	2023-12-17
K915078	North American Instrument Corp.	MORSE HEMOSTATIC CATHETER INTRODUCER SET	1992-06-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0783-2020	Abbott Medical	2	Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Z-0789-2020	Abbott Medical	2	Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential.
Z-0720-2020	Abbott Medical	2	CLASSIC Radiofrequency Cannula - Curved, 10 cm, SMK Compatible Electrode, REF C-1005-S - Product Usage: Disposable Radiofrequency Cannulae are provided in either straight, curved, or curved blunt geometries with a stylet inserted in the cannula. Cannulae are insulated except for the active tip. The active tip determines the size of the radiofrequency lesion.
Z-0003-2022	Medtronic Perfusion Systems	2	Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.
Z-0021-2018	OriGen Biomedical, Inc.	2	The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of the device. A thin sheath is used to cover and secure the wire layer and is heat shrunk into a permanent position.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008998256. Last updated year: 2026. Please use registration number 3008998256 when referencing this establishment in official correspondence.