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MULTIPLE
 Request for Information Form |
 Contact Information
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| Company Name | TERUMO CARDIOVASCULAR SYSTEMS CORP. |
| Address | 125 BLUE BALL RD. |
| City, State, Zip | ELKTON, MD 21921 |
| Country | US |
| FDA Owner/Operator Phone | 734-741-6238 |
| FDA Medical Specialty Code | PA - Pathology |
| FDA Product Code | KDT |
| FDA Classification Name | CONTAINER, SPECIMEN MAILER AND STORAGE, STERILE |
| FDA Device Classification Code | General Controls |
| FDA Regulation Number | 864.3250 |
| FDA Common Generic Name | BODILY FLUID WASTE CONTAINER |
| FDA Proprietary Device Name | MULTIPLE |
| FDA Owner / Operator Number | 1828100 |
| FDA Owner / Operator Name | TERUMO CARDIOVASCULAR SYSTEMS CORP. |
| FDA Establishment Registration Number | 1124841 |
| FDA Registered Establishment Name | TERUMO CARDIOVASCULAR SYSTEMS CORP. |
| FDA Operation Code(s) |
MM - Manufacturer MR - Remanufacturer RR - Repackager/Relabeller |
| FDA Listing Date | 04-01-03 |
| FDA Listing Status Code | Active |
| Differentiation | N/A |
| Keywords | N/A |
| Description | N/A |
| Brochure | N/A |
| Product Website | N/A |
Competitors of TERUMO CARDIOVASCULAR SYSTEMS CORP.
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 | AIKEN ENT. 80 ELIZABETH ST MILTON, ONTARIO, L9T 6R7 CA 905-875-3370 / 905-875-3370 |
URIOAID FEMALE URINE COLLECTION AID | URINE COLLECTION AID |
| 2 | ALPHAPOINTE ASSOCIATION FOR THE BLIND 7501 PROSPECT AVE. KANSAS CITY, MO 64132 US 816-237-2088 / 816-237-2088 |
BOTTLE,URINE SPECIMEN,90 ML - 3 OZ | BOTTLE,URINE SPECIMEN,90 ML - 3 OZ |
| 3 | ALPHA-TEC SYSTEMS, INC. 12019 N.E. 99TH ST., #1780 VANCOUVER, WA 98682 US 360-260-2779 / 360-260-2779 |
MULTIPLE | TRANSPORT CONTAINER |
| 4 | AM LABS, INC. 9125 SHOUP RD. COLORADO SPRINGS, CO 80908 US 719-495-9745 / 719-495-9745 |
CORD BLOOD COLLECTION SYSTEM | CORD BLOOD COLLECTION SYSTEM-STERILE |
| 5 | BECTON DICKINSON 1 BECTON DR. FRANKLIN LAKES, NJ 07417 US 201-847-6800 / 201-847-3247 |
MULTIPLE | VARIOUS SIZES AND TYPES OF URINE TUBES, KITS AND ACCESSORIES |
| 6 | BECTON, DICKINSON & CO. 150 SOUTH FIRST ST. BROKEN BOW, NE 68822 US 201-847-6800 / 308-872-6811 |
MULTIPLE | VARIOUS SIZES AND TYPES OF URINE TUBES, KITS AND ACCESSORIES |
| 7 | BIOMED PLASTICS CO. 8 ZHOUJING ROAD TAICANG, JIANGSU, 215421 CH / 310-849-5339 |
SPECIMEN COLLECTION SWABS | SPECIMEN COLLECTION SWABS |
| 8 | BIOSAFE LABORATORIES, INC. 100 FIELD DRIVE #240 LAKE FOREST, IL 60045 US 847-234-8111 / 773-693-0400 |
BIOSAFE BLOOD SAMPLE COLLECTION KIT | BLOOD SAMPLE COLLECTION AND MAILING SUPPLIES |
| 9 | C & A SCIENTIFIC CO., INC. 7241 GABE CT. MANASSAS, VA 20109 US 703-330-1413 / 703-330-1413 |
LAB SUPPLIES | |
| 10 | CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES 200 MCKNIGHT ST. JACKSONVILLE, TX 75766 US 847-689-8410 / 847-785-3323 |
NONE | SPECIMEN VIALS, SPECIMEN CONTAINERS AND PLACENTA BOWLS |
| 11 | COM-PAC INTL., INC. 800 INDUSTRIAL PARK RD. CARBONDALE, IL 62902 US 618-529-2421 / 618-529-2421 |
BITRAN SPECIMEN BAG | VARIOUS TYPES OF NON-STERILE OPEN AND RECLOSABLE PLASTIC BAGS FOR LIQUIDS |
| 12 | COPAN DIAGNOSTICS, INC. 2175 SAMPSON AVE., SUITE 124 CORONA, CA 91719 US 39-030-2687211 / 800-216-4016 |
COPAN PLAIN SWABS | SWABS |
| 13 | COPAN ITALIA VIA F. PEROTTI, 10 BRESCIA, 25125 IT 39-030-2687211 / 800-216-4016 202 |
COPAN PLAIN SWABS | SWABS |
| 14 | COVIDIEN LP, FORMERLY REGISTERED AS KENDALL 400 MAPLE ST. COMMERCE, TX 75428 US 508-261-8587 / 508-261-8587 |
CONTAINER, SPECIMEN MAILER AND STORAGE | SPECIMEN CUP |
| 15 | COVIDIEN LP, FORMERLY REGISTERED AS KENDALL 1222 SHERWOOD RD. NORFOLK, NE 68701 US 508-261-8587 / 508-261-8587 |
E-ZEE NEST SAMLE CUPS | SPECIMEN CONTAINERS |
| 16 | DOXTECH, LLC 10025 S.W. ALLEN BLVD. BEAVERTON, OR 97005 US 503-641-1865 / 503-641-1865 |
DOX,DOXTECH | URINE SPECIMEN COLLECTION CONTAINER AND SHIPPING KIT WITH AND WITHOUT TEMPERATUR |
| 17 | EVERGREEN INDUSTRIES, INC. 2254-2300 EAST 49TH ST. VERNON, CA 90058 US 323-583-1331 / 323-583-1331 |
EVERGREEN CONTAINER, SPECIMEN MAILER AND STORAGE | STERILE AND NON-STERILE CONTAINER |
| 18 | EVOLUTION DIAGNOSTIC LABORATORY, INC. 475 ROUTE 70, SUITE 201 LAKEWOOD, NJ 08701 US 732-840-1447 / 732-363-4777 |
SPERM CONFIRM | SEMEN COLLECTION CONTAINER |
| 19 | EXAKT TECHNOLOGIES, INC. 7416 BROADWAY EXTENSION, SUITE E OKLAHOMA CITY, OK 73116 US 405-848-5800 / 405-848-5800 |
CONTAINER, SPECIMEN MAILER AND STORAGE | SHIPPING CONTAINER FOR RETRIEVED MEDICAL DEVICES OR INFECTIOUS SUBSTANCES |
| 20 | FISHER DIAGNOSTICS 8365 VALLEY PIKE MIDDLETOWN, VA 22645 US 412-490-8425 / 540-869-8163 |
MULTIPLE | VARIOUS TYPES OF SPECIMEN CONTAINERS |
| 21 | FORENSIC TECHNOLOGIES, INC. 1976 WOODDALE DRIVE., UNIT 20 SUITE 2B WOODBURY, MN 55125 US 651-738-1974 / 651-738-1774 |
QUALEX URINE AND/OR BLOOD TRANSPORT SYSTEM | URINE AND/OR BLOOD TRANSPORT SYSTEM |
| 22 | HERITAGE LABS INTL., LLC 1111 WEST OLD 56 HWY. OLATHE, KS 66061 US / 913-764-1045 |
MULTIPLE | VARIOUS |
| 23 | HOME ACCESS HEALTH CORP. 2401 W. HASSELL RD. SUITE 1510 HOFFMAN ESTATES, IL 60169 US 847-781-2526 / 847-781-2522 |
HOME ACCESS MICRO SERUM SPECIMEN COLLECTION KIT | MICRO SERUM SPECIMEN COLLECTION KIT AND MAILING SUPPLIES |
| 24 | HYCOR BIOMEDICAL, INC. 7272 CHAPMAN AVE. GARDEN GROVE, CA 92841 US 714-933-3107 / 714-933-3107 |
KOVA KAP | CENTRIFUGE TUBE CAP |
| 25 | KABE LABORTECHNIK GMBH JAGERHOFSTR. 17 NUMBRECHT, 51588 GM / 914-969-7900 |
CONTAINER, SPECIMEN MAILER AND STORAGE | CONTAINERS, SPECIMEN MAILER, TUBES |
| 26 | KUNSHAN DEYI PLASTIC CO., LTD. NO. 38 LIDU ROAD, QIAN DENG TOWN KUNSHAN CITY, JIANGSU, 215343 CH 86-512-57402718 / 201-818-5288 |
CONTAINER, SPECIMEN MAILER AND STORAGE, STERILE PATHOLOGY | SPECIMEN BAGS, VARIOUS SIZES, BIOHAZARD |
| 27 | LABONE, INC. 10101 RENNER BLVD. LENEXA, KS 66219 US 913-888-1770 / 913-577-1516 |
CONTAINER, SPECIMEN MAILER AND STORAGE | SPECIMEN TRANSPORT AND STORAGE KIT |
| 28 | LONGWIN PLASTICS CO., LTD. 20-220, SAN MIN RD., SEC. 2 PAN CHIAO TAIPEI, TW 886-296-26058 / 415-495-2495 |
CYTOLOGY SLIDE-MAILER | SLIDE MAILER |
| 29 | M&M INDUSTRIES, INC. 316 CORPORATE PL. CHATTANOOGA, TN 37419 US 800-331-5305 / 800-331-5305 |
LIFE LATCH | VARIOUS |
| 30 | MATRITECH, INC. 330 NEVADA ST., 2ND FL. NEWTON, MA 02460 US 617-928-0820 / 617-658-5246 |
MATRITECH NMP22 URINE COLLECTION KIT | URINE COLLECTION KIT |
| 31 | MEDEGEN MEDICAL PRODUCTS LLC 11060 IRMA DR. NORTHGLENN, CO 80233 US 303-457-2400 / 901-867-4228 |
MULTIPLE | VARIOUS |
| 32 | MEDISAFE 12832 HWY 155 S. TYLER, TX 75703 US 903-509-8765 / 903-509-8765 |
CONTAINER, SPECIMEN MAILER AND STORAGE | HEMATOLOGY BLOOD COLLECTION TRAY |
| 33 | MERIDIAN BIOSCIENCE, INC. 3471 RIVER HILLS DR. CINCINNATI, OH 45244 US 513-271-3700 / 513-271-3700 229 |
PARAPAK | TRANSPORT CONTAINER |
| 34 | NINGBO YONGDA TEXTILES LTD. BLDG 5, SEC. G5, NINGBO ECONOMIC & TECHNICAL DVLP NINGBO, ZHEJIANG PROVINCE, 315803 CH 86-574-87258517 / 805-304-8883 |
SPC & MULTIPLE BRANDS | SPC BIOHAZARD MAILER/SPECIMEN BAGS, STERILE |
| 35 | O.R. SURGICAL CO., INC. 120 MONTLIEU AVE. GREENSBORO, NC 27409 US 336-855-6714 / 336-855-6714 |
SPECIMEN TRAP FILTER | SPECIMEN FILTER |
| 36 | PARA SCIENTIFIC CO. 297 CEDAR LN. FAIRLESS HILLS, PA 19030 US 215-736-0225 / 215-736-0225 |
PARA NO SUB LIL ORDOR VIAL/BOTTLE AND MULTIPLE | SPECIMEN PRE-FILLED VIAL/BOTTLE/CONTAINER |
| 37 | PORTABLE MEDICAL LABORATORIES, INC. 544 SOUTH NARDO AVE. SOLANA BEACH, CA 92075 US 858-755-7385 / 858-755-7385 |
SUPPORT MODULE | SPECIMEN COLLECTION AND TRANSPORT SYSTEM |
| 38 | RAYMOND A. LAMB, INC. 5409 LUMLEY ROAD DURHAN, NC 27703 US 919-387-1237 / 919-387-1237 |
MULTIPLE TYPES OF LABSTACK FILING CABINET | VARIOUS TYPES OF SLIDE/CASSETTE/BLOCK FILING CABINET AND ACCESSORIES |
| 39 | SAKURA FINETEK U.S.A., INC. 1750 WEST 214TH ST. TORRANCE, CA 90501 US 81-332-701666 / 310-783-5076 |
CYTO-TEK MAILER | SLIDE MAILER |
| 40 | SALUBRIS BIYOTEKNOLOJI URUNLERI SANAYI VE TICARET IDEALTEPE MAHALLESI AKGUVERCIN SOKAK NO: 9 MALTEPE ISTANBUL, 34841 TU 90-216-5184660 / 800-326-1484 |
SALUBRIS BIOLOGICAL SPECIMEN TRANSPORT & STORAGE CONTAINERS | SPECIMEN TRANSPORT & STORAGE CONTAINER |
| 41 | SAMCO SCIENTIFIC CORP. 1050 ARROYO AVE. SAN FERNANDO, CA 91340 US 412-490-8425 / 412-490-8425 |
MULTIPLE | VARIOUS SPECIMEN MAILERS & STORAGE CONTAINERS |
| 42 | SAN PABLO COMMERCIAL 1827 WILLIAMS STREET SIMI VALLEY, CA 93065 US 805-304-8883 / 805-304-8883 |
SPC BIOHAZARD SPECIMEN BAGS,STERILE | STERILE BIOHAZARD SPECIMEN,MAILER BAGS |
| 43 | SHANGHAI HUA YUE PACKAGING PRODUCTS CO., LTD. NO.228, ZHAI XING RD. XINSI, ZHELIN TOWN FENG XIAN DISTRICT, SHANGHAI, 201416 CH 86-21-50301896 / 86-21-50301896 |
HUAYUE STERILE SPECIMEN MAILER & STORAGE CONTAINER | STERILE SPECIMEN MAILER & STORAGE CONTAINER |
| 44 | SIRCHIE FINGER PRINT LABORATORIES, INC. 100 HUNTER PL. YOUNGSVILLE, NC 27596 US 919-554-2244 / 919-554-2244 |
CC100 SEX CRIMES INVESTIGATION KIT | SPECIMEN MAILER AND STORAGE CONTAINER |
| 45 | STARPLEX SCIENTIFIC, INC. 50-A STEINWAY BLVD. ETOBICOKE, ONTARIO, M9W 6Y3 CA 416-674-7474 / 416-674-7474 |
STARPLEX SPECIMEN CONTAINERS | VARIOUS STERILE AND NON-STERILE SPECIMEN CONTAINERS AND COLLECTORS |
| 46 | STRECK 7002 SOUTH 109TH ST. OMAHA, NE 68128 US 800-843-0912 / 402-537-5313 |
MULTIPLE PRODUCTS | TRANSPORT REAGENT |
| 47 | SUZHOU JIN SHENG PLASTIC CO., LTD. NO. 8 XINSHI RD., XINJIA IND. ESTATE, SHIHU RD.(W) SUZHOU, JIANGSU, 215128 CH 86-512-65616868 / 86-512-65616868 |
SPECIMEN CUP AND DENTURE CUP | SPECIMEN CUP AND DENTURE CUP |
| 48 | TAIZHOU HAIDA PLASTIC & RUBBER PACKAGING CO. LTD NO.18 XINGYUAN RD,TAIDONG DEVELOPING DISTRICT TAIZHOU CITY,JIANGSU, CH 86-523-6275804 / 86-523-6275804 |
TAIZHOU STERILE SPECIMEN TRANSPORT CONTAINER | STERILE SPECIMEN TRANSPORT CONTAINER |
| 49 | TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 28 HOWE ST. ASHLAND, MA 01721 US 734-741-6238 / 800-283-7866 7420 |
MULTIPLE | BODILY FLUID WASTE CONTAINER |
| 50 | THERMO FISHER SCIENTIFIC INC. 171 INDUSTRY DR. PITTSBURGH, PA 15275 US / 269-544-5614 |
CYTOSPIN COLLECTION FLUID (CUPS) | SACCOMANNO FLUID (CUPS) |
| 51 | TIP, INC. 2 MUIRFIELD LN. ST. LOUIS, MO 63141 US 314-576-2678 / 314-434-8583 |
BREAST SPECIMEN CONTAINER | |
| 52 | TRI-TECH, INC. 4019 EXECUTIVE PARK BLVD.,S.E. SOUTHPORT, NC 28461 US 910-457-6600 / 910-457-6600 |
TRI-TECH URINE SPECIMEN KIT | |
| 53 | UNIFLEX, INC. 383 WEST JOHN ST. HICKSVILLE, NY 11802 US / 516-932-2000 |
NO PROPRIETARY NAME LISTED | LIQUID TIGHT SPECIMEN TRANSPORT BAG |
| 54 | WANG QUIZHEN TRADE CORP. RM. 601, 1228 ZHONG SHAN RD. SOUTH SHANGHAI, 200011 CH 21-631-30515 / 703-330-1413 |
PREMIERE MICROSCOPE SLIDE MAILER | MAILERS |
| 55 | WARE-MEDICS GLASS WORKS, INC. 55 W. RAILROAD AVE., BLDG. 3A GARNERVILLE, NY 10923 US 845-429-6950 / 845-429-6950 |
CONTAINER, SPECIMEN | CONTAINER, SPECIMEN |
| 56 | WHITNEY PRODUCTS, INC. 6153 MULFORD ST., #C NILES, IL 60714 US 847-470-9300 / 847-470-9300 |
TERMINAL SPECIMEN KEEPER | VARIOUS SIZES OF SPECIMEN STORAGE CONTAINERS |
| 57 | ZENITH MEDICAL, INC. 10064 MESA RIDGE COURT SUITE 218 SAN DIEGO, CA 92121 US 858-535-0216 / 858-535-0216 |
ENDOSAC | SPECIMAN RETRIEVAL POUCH |
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