Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007143859

FEI Number

3007143859

Entity Name

Sedation Systems LLC

City/State/Country

Tierra Verde, FL, US

Establishment Address

150 Pinellas Bayway South, Suites 207, 208, Tierra Verde, FL 33715, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Sedation System, LLC (Owner Number: 10026795)

Owner / Operator Contact Address

150 Pinellas Bayway South, Suites 207, 208, Tierra Verde, FL 33715, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K160950

PMA Number

N/A

All Registered Proprietary Names

Disposable Breathing Circuit and Mask Kit Nitroscav

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OFP	Anesthesia Breathing Circuit Kit (Adult & Pediatric)	Anesthesiology	Class 1	868.5240	2014-03-21
BTA	Pump, Portable, Aspiration (Manual Or Powered)	General, Plastic Surgery	Class 2	878.4780	2017-05-11
CBN	Apparatus, Gas-Scavenging	Anesthesiology	Class 2	868.5430	2017-05-11

Official Correspondent

Ramses Nashed

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Sedation System, LLC

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0035-2007	Haemonetics Corporation	2	SmartSuction Harmony Powered Suction Device Model Number: HAR-E-115-US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007143859. Last updated year: 2026. Please use registration number 3007143859 when referencing this establishment in official correspondence.