Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013976593

FEI Number

1037230

Entity Name

SEA-LONG MEDICAL SYSTEMS, LLC

City/State/Country

Waxahachie, TX, US

Establishment Address

2498 FM66, Building 1021, Waxahachie, TX 75167, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Sea-long Medical Systems, LLC (Owner Number: 10056562)

Owner / Operator Contact Address

135 Tranquil Pl., Waxahachie, TX 75167, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

HBOT Oxygen Hood

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FOG	Hood, Oxygen, Infant	Anesthesiology	Class 1	868.5700	2017-12-21

Official Correspondent

Melissa Nogic

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Sea-long Medical Systems, 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 3013976593. Last updated year: 2026. Please use registration number 3013976593 when referencing this establishment in official correspondence.