Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006793151

FEI Number

3006793151

Entity Name

GURIN PRODUCTS LLC

City/State/Country

Tustin, CA, US

Establishment Address

2522 Chambers Rd Ste 100, Tustin, CA 92780, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Gurin Products, LLC (Owner Number: 10031258)

Owner / Operator Contact Address

2522 Chambers Rd, Suite 100, Tustin, CA 92780, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

GURIN SANTAMEDICAL SM-165 SANTAMEDICAL SM-110 GURIN GO-410 SM-150Y SANTAMEDICAL SM-150 SANTAMEDICAL SM-165-S SM-1100S SM-110 SM-240 SM-150BL SM-230 SM-150G SM110OS SM-1100P SM-165-S SM-165 GO-410 SM-1100B JPD-500E SM-519BR-BL

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OCH	Oximeter, Infrared, Sporting, Aviation	Cardiovascular	Class 2	870.2700	2017-10-20

Official Correspondent

Sanjay Gupta

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Gurin Products, 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 3006793151. Last updated year: 2026. Please use registration number 3006793151 when referencing this establishment in official correspondence.