ZENITH 11 MEDICAL LLC

FDA Device Registration & Listing · Key Largo, FL, US · Registration 3031282706

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3031282706
FEI Number
3031282706
Entity Name
ZENITH 11 MEDICAL LLC
City/State/Country
Key Largo, FL, US
Establishment Address
99198 Overseas Hwy, Ste 12, Key Largo, FL 33037, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Zenith 11 Medical LLC (Owner Number: 10090757)
Owner / Operator Contact Address
99198 Overseas Hwy, Ste 12, Key Largo, FL 33037, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

ARM SUPPORT BOARD Radial Artery Compression Tourniquets Push Click Y Connector Kit

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NOD Board, Arm (With Cover), Non-Sterile General, Plastic Surgery Class 1 878.3910 2025-09-29
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2025-09-19
DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Cardiovascular Class 2 870.4290 2025-09-29

Official Correspondent

Parth Patel

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Zenith 11 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
K915301 Advance Medical Designs, Inc. ADVANCE STOPCOCK/HIGH PRESSURE STOPCOCK 1992-12-11

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031282706. Last updated year: 2026. Please use registration number 3031282706 when referencing this establishment in official correspondence.
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