Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009057691

FEI Number

3009057691

Entity Name

LIFE SCIENCE LOGISTICS, LLC

City/State/Country

Brownsburg, IN, US

Establishment Address

1105 East Northfield Drive, Brownsburg, IN 46112, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

LifeScience Logistics, LLC (Owner Number: 10051139)

Owner / Operator Contact Address

3100 Olympus Blvd, Suite 100, Coppell, TX 75019, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K214048

PMA Number

N/A

All Registered Proprietary Names

Vibrating Mesh Nebulizer flume catheter Stratamark Strataderm Stratamed StrataXRT Stratacel Flume catheter Millipede 088 Access Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2021-07-16
EPT	Microscope, Surgical	General, Plastic Surgery	Class 1	878.4700	2021-07-16
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2025-03-11
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2025-01-20
MDA	Elastomer, Silicone, For Scar Management	General, Plastic Surgery	Class 1	878.4025	2016-02-08
NWB	Endoscope, Accessories, Narrow Band Spectrum	Gastroenterology, Urology	Class 2	876.1500	2021-07-16
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2021-07-16
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2021-07-16
OWN	Confocal Optical Imaging	Gastroenterology, Urology	Class 2	876.1500	2021-07-16
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2021-07-16
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2016-02-08
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2025-01-20
KOB	Catheter, Suprapubic (And Accessories)	Gastroenterology, Urology	Class 2	876.5090	2025-01-20
QJP	Catheter, Percutaneous, Neurovasculature	Cardiovascular	Class 2	870.1250	2023-03-27

Official Correspondent

Paul Hayward

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

LifeScience Logistics, 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
K163485	Adherium (Nz), Ltd.	SmartTouch	2017-08-30
K781467	Travenol Laboratories, S.A.	U-FLOAT VALVE 2D9023	1978-09-07
K233013	Silq Technologies Corporation	2-Way 100% Silicone Cleartract Catheter	2024-01-23
K914997	Conmedcorp	ASP-IRRATOR	1992-01-07
K153773	Olympus Medical Systems Corp.	Disposal Lens Cleaning Sheath	2016-11-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.
Z-0029-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.
Z-0023-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Separator Abdominal Access System REF: C0604 15 x 100mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0024-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Separator Abdominal Access System REF:C0605 15x100mm Threaded Separator System with Universal Seal, for laparoscopic procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009057691. Last updated year: 2026. Please use registration number 3009057691 when referencing this establishment in official correspondence.