OMNIPOD INSULIN MANAGEMENT SYSTEM MANUFACTURED BY INSULET CORPORATION

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OMNIPOD INSULIN MANAGEMENT SYSTEM

Request for Information Form	Contact Information
Company Name	INSULET CORPORATION
Address	9 OAK PARK DR.
City, State, Zip	BEDFORD, MA 01730
Country	US
FDA Owner/Operator Phone	781-457-4812
FDA Medical Specialty Code	CH - Clinical Chemistry
FDA Product Code	LFR
FDA Classification Name	GLUCOSE DEHYDROGENASE, GLUCOSE
FDA Device Classification Code	Standards
FDA Regulation Number	862.1345
FDA Common Generic Name	BLOOD GLUCOSE MONITOR
FDA Proprietary Device Name	OMNIPOD INSULIN MANAGEMENT SYSTEM
FDA Owner / Operator Number	9056196
FDA Owner / Operator Name	INSULET CORPORATION
FDA Establishment Registration Number	3004464228
FDA Registered Establishment Name	INSULET CORPORATION
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	01-11-05
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of INSULET CORPORATION

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	ABBOTT DIABETES CARE INC. 1360 SOUTH LOOP RD. ALAMEDA, CA 94502 US 847-937-6100 / 847-938-3471	SOFT-TACT DIABETES MANAGEMENT SYSTEM	AUTOMATED GLUCOSE MONITOR AND TEST STRIPS
2	ABBOTT DIABETES CARE LIMITED RANGE RD. WITNEY OXON, OX29 OYL UK 847-937-6100 / 847-938-3471	SOFT-TACT DIABETES MANAGEMENT SYSTEM	AUTOMATED GLUCOSE MONITOR AND TEST STRIPS
3	ARKRAY FACTORY INC. 1480 KOJI,KONAN-CHO, KOKA-SHI SHIGA,, 520-3306 JA 81-75-6628964 / 81-748-867298	GLUCOCARD X-METER BLOOD GLUCOSE MONITORING SYSTEM	BLOOD GLUCOSE MONITORING SYSTEM
4	ARKRAY FACTORY USA, INC. 5182 WEST 76TH ST. MINNEAPOLIS, MN 55439 US 81-75-6628964 / 952-646-3168	GLUCOCARD X-METER BLOOD GLUCOSE MONITORING SYSTEM	BLOOD GLUCOSE MONITORING SYSTEM
5	ARKRAY, INC. 57 NISHIAKETA-CHO, HIGASHI-KUJO, MINAMI-KU KYOTO, 601-8045 JA 81-75-6628964 / 81-748-867298	GLUCOCARD X-METER BLOOD GLUCOSE MONITORING SYSTEM	BLOOD GLUCOSE MONITORING SYSTEM
6	BAYER HEALTHCARE LLC 555 WHITE PLAINS RD. 5TH FLOOR TARRYTOWN, NY 10591 US 914-524-2955 / 574-262-6372	ASCENSIA CONTOUR BLOOD GLUCOSE SYSTEM	TEST FOR BLOOD GLUCOSE
7	BENCHMARK ELECTRONICS, INC. 4065 THEURER BLVD. WINONA, MN 55987 US 979-849-6550 / 507-453-4891	MEDISENSE PRECISION PCX CARE MANAGEMENT SYSTEM	GLUCOSE TEST SYSTEM
8	CAMBRIDGE SENSORS LIMITED UNITS 9&10 CARDINAL PARK GODMANCHESTER HUNTINGDON, CAMBRIDGESHIRE, PE29 2XG UK 441-480-482920 / 441-480-482920	SENOVA	BLOOD GLUCOSE MONITORING SYSTEM
9	HEMOCUE AB KUVETTGATAN 1 ANGELHOLM, SE-262 71 SW 464-314-5 82 00 / 800-881-1611 110	HEMOCUE B-GLUCOSE SYSTEM/ANALYZER	HEMOCUE GLUCOSE TEST
10	LRE MEDICAL GMBH HOFER STRASSE 5 NOERDLINGEN, 86720 GM 49-908-18000 / 208-765-8000 1247	SENOVA	BLOOD GLUCOSE MONITOR
11	PANASONIC SHIKOKU ELECTRONICS CO., LTD. 2131-1 MINAMIGATA, TOON, EHIME, 791-0395 JA 81-89-96611-2822 / 81-89-9661163	ASCENSIA CONTOUR BLOOD GLUCOSE MONITORING SYSTEM	GLUCOSE TEST SYSTEM
12	PANASONIC SHIKOKU ELECTRONICS CO., LTD. 110 OAZA-INOSHIRI AZA-NISHIUENO WAKIMACHI,MIMA,TOKUSHIMA, 779-3603 JA 81-89-96611-2822 / 81-89-9661163	ASCENSIA CONTOUR BLOOD GLUCOSE MONITORING SYSTEM	GLUCOSE TEST SYSTEM
13	PHARMA SUPPLY, INC. 3381 FAIRLANE FARMS RD. WELLINGTON, FL 33414 US 800-870-6831 / 800-870-6831	MULTIPLE BRANDS	VARIOUS BLOOD GLUCOSE METERS AND REAGENT TEST STRIPS
14	ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. INDIANAPOLIS, IN 46250 US / 317-521-2834	ACCU-CHEK ADVANTAGE H TEST STRIPS	BLOOD GLUCOSE TESTING DEVICE
15	ROCHE DIAGNOSTICS CORP. MARGINAL RD., PUNTO ORO INDUSTRIAL DEVELOPMENT PONCE, PR 00731 US 317-521-2386 / 317-521-2834	TEST STRIPS (MULTIPLE BRANDS)	GLUCOSE TEST STRIPS
16	ROCHE DIAGNOSTICS GMBH FRIEDRICH-EBERT-STRABE 100 MANNHEIM, 68167 GM 49-621-7670 / 317-521-2834	ACCUCHECK COMPACT, ACCUCHECK INFORM, ACCUCHECK ADVANTAGE	GLUCOSE MONITORING SYSTEM
17	RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS 2 FRASER ROAD, KIRKTON CAMPUS LIVINGSTON W. LOTHIAN SCOTLAND, EH54 7BU UK / 757-224-0177	BLOOD GLUCOSE MONITORING SYSTEM	BLOOD GLUCOSE MONITORING SYSTEM
18	RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS 1600 DISK DR. PLOVER, WI 54467 US / 757-224-0177	SOFT-TACT DIABETES MANAGEMENT SYSTEM	AUTOMATED GLUCOSE MONITOR AND TEST STRIPS
19	RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS 10 TOH GUAN RD, 05-06 TT INTERANTIONAL TRADEPARK SINGAPORE, 608838 SN 65-353-214907387 / 757-224-0177	BLOOD GLUCOSE MONITORING SYSTEM	BLOOD GLUCOSE MONITORING SYSTEM
20	SANMINA-SCI RATHEALY ROAD FERMOY, CORK, EI / 353-258-2613	ACCU-CHEK COMPACT,ACCU-CHEK ACTIVE	GLUCOSE MONITORING SYSTEM
21	SANMINA-SCI (SHENZHEN) LTD. 1 NAN LING ROAD, XIN ER CUN, SHA JIN ZHEN, BAO AN SHENZHEN, GUANG DONG, 518125 CH / 86-755-27250088	ACCU-CHEK ACTIVE S	GLUCOSE MONITORING SYSTEM
22	SANMINA-SCI USA, INC. 13000 SOUTH MEMORIAL PKWY. HUNTSVILLE, AL 35803 US / 256-882-4800	ACCU-CHECK VOICEMATE	GLUCOSE MONITORING SYSTEM

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