OCEANA MEDICAL LLC.

FDA Device Registration & Listing · Matawan, NJ, US · Registration 3038103152

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
3038103152
FEI Number
3038103152
Entity Name
OCEANA MEDICAL LLC.
City/State/Country
Matawan, NJ, US
Establishment Address
83 Letts Ct, Matawan, NJ 07747, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Oceana Medical LLC. (Owner Number: 10093232)
Owner / Operator Contact Address
83 Letts Court, Matawan, NJ 07747, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Infant/Pediatric One-Man/Two-Man/Advanced Airway CPR Visual Guidance Infant/Pediatric One-Man/Two-Man CPR Visual Guidance Infant/Pediatric One-Man/Two-Man CPR Guidance Adult One-Man/Two-Man/Advanced Airway CPR Visual Guidance Infant/Pediatric One-Man/Two-Man/Emergency AIrway CPR Guidance Adult One-Man/Two-Man CPR Guidance PaceAid Adult One-Man/Two-Man CPR Visual Guidance Adult One-Man/Two-Man/Emergency Airway CPR Guidance

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PMK Cpr Aid Device Without Feedback Cardiovascular Class 1 870.5210 2025-04-15

Official Correspondent

Colleen McGowan

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Oceana Medical LLC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038103152. Last updated year: 2026. Please use registration number 3038103152 when referencing this establishment in official correspondence.
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