STATSPIN ILLUMINATED MICRO HCT TUBE READER; PROD.#HR05; SAFE MANUFACTURED BY IRIS SAMPLE PROCESSING

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Request for Information Form	Contact Information
Company Name	IRIS SAMPLE PROCESSING
Address	60 GLACIER DRIVE
City, State, Zip	WESTWOOD, MA 02090
Country	US
FDA Owner/Operator Phone	818-709-1244 7129
FDA Medical Specialty Code	HE - Hematology
FDA Product Code	GHY
FDA Classification Name	HEMATOCRIT, TUBE, RACK, SEALER, HOLDER
FDA Device Classification Code	Standards
FDA Regulation Number	864.6400
FDA Common Generic Name	MICRO HEMATOCRIT TUBE READER AND ASSOC.PRODUCTS
FDA Proprietary Device Name	STATSPIN ILLUMINATED MICRO HCT TUBE READER; PROD.#HR05; SAFE
FDA Owner / Operator Number	2023446
FDA Owner / Operator Name	IRIS INTERNATIONAL INC., A DIVISION OF IRIS IRIS I
FDA Establishment Registration Number	1221015
FDA Registered Establishment Name	IRIS SAMPLE PROCESSING
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	07-22-92
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

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1	ALLIANCE MEDICAL PRODUCTS, INC. 909 EAST MAIN RD. MIDDLETOWN, RI 02842 US 401-841-5116 / 800-697-8112	SAF-T-HOLDER 10-1500	BLOOD TUBE HOLDER
2	BECTON DICKINSON 1 BECTON DR. FRANKLIN LAKES, NJ 07417 US 201-847-6800 / 201-847-3247	SEAL-EASE TUBE SEALER AND HOLDER	TUBE SEALER AND HOLDER
3	CHASE SCIENTIFIC GLASS, INC. 234 CARDIFF VALLEY RD. ROCKWOOD, TN 37854 US 412-490-8425 / 412-490-8425	MULTIPLE	MULTIPLE
4	CORNING, INC. ONE RIVERFRONT PLAZA, BF CORNING, NY 14831 US 607-974-9000 / 607-974-0360		HEMATOCRIT TUBES, RACKS, SEALER, HOLDER
5	DRUMMOND SCIENTIFIC CO. 500 PKWY. BROOMALL, PA 19008 US 610-353-0200 / 610-353-0200	HEMATOCRIT TUBES	HEMATOCRIT TUBES
6	GYRUS MEDICAL GMBH GOTENSTRASSE 3 TUTTLINGEN, 78532 GM 011-44-189219750 / 508-804-2739	HEMATOCRIT, TUBE, RACK, SEALER, HOLDER	BURR RACK, ETC.
7	KABE LABORTECHNIK GMBH JAGERHOFSTR. 17 NUMBRECHT, 51588 GM / 914-969-7900	HEMATOCRIT CAPILLARIES- SAFE-T-FILL	HEMATOCRIT CAPILLARIES- SAFE-T-FILL
8	R. LEWIS, INC. 3700 METAIRIE HEIGHTS AVE. METAIRIE, LA 70002 US 504-834-4900 / 504-834-4900	THE LEWIS TUBE HOLDER	ENDOTRACHEAL TUBE HOLDER DEVICE
9	TINOPAL SURGICAL CORP. (PVT), LTD. UNIT #1, 55/57-B. SMALL INDUSTRIES ESTATE SIALKOT, PUNJAB, 51311 PK 92-52-3255454 / 92-52-3552298	RACK, SURGICAL INSTRUMENTS	RACK, SURGICAL INSTRUMENTS
10	WARE-MEDICS GLASS WORKS, INC. 55 W. RAILROAD AVE., BLDG. 3A GARNERVILLE, NY 10923 US 845-429-6950 / 845-429-6950	HEMATOCRIT TUBES	HEMATOCRIT TUBES