CALIBRATORS, ETHYL ALCOHOL MANUFACTURED BY GYRUS MEDICAL GMBH

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Request for Information Form	Contact Information
Company Name	GYRUS MEDICAL GMBH
Address	GOTENSTRASSE 3
City, State, Zip	TUTTLINGEN,
Country	GM
FDA Owner/Operator Phone	011-44-189219750
FDA Medical Specialty Code	TX - Clinical Toxicology
FDA Product Code	DNN
FDA Classification Name	CALIBRATORS, ETHYL ALCOHOL
FDA Device Classification Code	Standards
FDA Regulation Number	862.3200
FDA Common Generic Name	ANTIFOG SOLUTION
FDA Proprietary Device Name	CALIBRATORS, ETHYL ALCOHOL
FDA Owner / Operator Number	9018965
FDA Owner / Operator Name	GYRUS GROUP PLC
FDA Establishment Registration Number	9680562
FDA Registered Establishment Name	GYRUS MEDICAL GMBH
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	04-26-96
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Our records indicate that the following medical device companies may manufacture a similar device.

	Company Name / Address / Phone	Proprietary Device Name	Common Generic Device Name
1	BECKMAN COULTER, INC. 2470 FARADAY AVE. CARLSBAD, CA 92008 US 714-871-4848 / 714-993-5321 8383	MULTIPLE	ETHYL ALCOHOL CALIBRATORS
2	DADE BEHRING, INC. 500 GBC DR, MAILSTOP 514 NEWARK, DE 19714 US 847-267-5300 / 302-631-6311	MULTIPLE	VARIOUS ALCOHOL CALIBRATORS
3	EMD CHEMICALS INC. 480 DEMOCRAT RD. GIBBSTOWN, NJ 08027 US 011-49-6151726060 / 856-423-6300 315	CAP ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS	VARIOUS CONCENTRATIONS OF ALCOHOL STANDARDS
4	INTOXIMETERS, INC. 8110 LACKLAND RD. ST. LOUIS, MO 63114 US 314-429-4000 / 314-429-4000	MULTIPLE	VARIOUS MODELS OF ALCOHOL BREATH TRAPPING AND ANALYZING DEVICES
5	JAS DIAGNOSTICS, INC. 7220 NW 58TH ST. MIAMI, FL 33166 US 305-418-2320 / 305-418-2320	ETHYL ALCOHOL STANDARD	ETHANOL CALIBRATOR/ CONTROLS
6	MICROGENICS CORP. 46360 FREMONT BLVD FREMONT, CA 94538 US 412-490-8425 / 412-490-8425	MULTIPLE	ETHYL ALCOHOL CALIBRATORS
7	MICROGENICS CORPORATION 44560-44660 OSGOOD RD FREMONT, CA 94539 US 412-490-8425 / 412-490-8425	MULTIPLE	ETHYL ALCOHOL CALIBRATORS
8	NERL DIAGNOSTICS LLC. 14 ALMEIDA AVE. EAST PROVIDENCE, RI 02914 US 412-490-8425 / 412-490-8425	MULTIPLE	ETHYL ALCOHOL CALIBRATORS
9	ORTHO-CLINICAL DIAGNOSTICS, INC. 601 LEE RD. ROCHESTER, NY 14652 US 585-453-4469 / 585-453-3768	MULTIPLE	ALCOHOL CALIBRATOR
10	VERICHEM LABORATORIES, INC. 90 NARRAGANSETT AVE. PROVIDENCE, RI 02907 US 401-461-0180 / 401-461-0180	NO PROPRIETARY NAME LISTED	NO COMMON NAME LISTED