Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021187119

FEI Number

3021187119

Entity Name

N8 MEDICAL LLC

City/State/Country

Dublin, OH, US

Establishment Address

565 Metro Place South, Suite 300, Dublin, OH 43017, US

Establishment Type(s)

Manufacture Device in the United States for Export Only

Owner / Operator

N8 Medical LLC (Owner Number: 10083706)

Owner / Operator Contact Address

565 Metro Place South, Suite 300, Dublin, OH 43017, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CeraShield Endotracheal Tube

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2021-12-13

Official Correspondent

Glenn Brunner

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

N8 Medical 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
K233341	Covidien, LLC	Shiley Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410)	2024-05-20
K243785	Covidien, LLC	Shiley Oral/Nasal Tracheal Tube with TaperGuard Cuff Reinforced, Murphy Eye Shiley Tracheal Tube TaperGuard Cuff Reinforced with Stylet Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley Oral/Nasal Tracheal Tube Cuffless Reinforced	2025-09-25

Similar Registrations

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3010400865	WELL LEAD MEDICAL CO. LTD	GUANGZHOU Guangdong, CN
1420054	LSL HEALTHCARE	Niles, IL, US
9681384	Covidien	Ciudad Juarez Chihuahua, MX
3010220595	Synergy Sterilisation (M) Sdn Bhd	Kuala Ketil Kedah, MY
3016548968	QUADRANT TECHNOLOGIES, LLC	Grayslake, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021187119. Last updated year: 2026. Please use registration number 3021187119 when referencing this establishment in official correspondence.