Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016558817

FEI Number

3016558817

Entity Name

GLOBAL CALIBRATION GASES

City/State/Country

Sarasota, FL, US

Establishment Address

1090 Commerce Blvd N, Sarasota, FL 34243, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Global Calibration Gases (Owner Number: 10062666)

Owner / Operator Contact Address

1090 Commerce Blvd N, Sarasota, FL 34243, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

45 ppm Nitric Oxide balance Nitrogen 10 ppm Nitrogen Dioxide balance Nitrogen GAS, CALIBRATION

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BXK	Gas, Calibration (Specified Concentration)	Anesthesiology	Class 1	868.6400	2020-02-27

Official Correspondent

Dale Hyler

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Global Calibration Gases

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 3016558817. Last updated year: 2026. Please use registration number 3016558817 when referencing this establishment in official correspondence.