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DISPOSABLE SUCTION
 Request for Information Form |
 Contact Information
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| Company Name | TGI DIRECT |
| Address | 3085 E. REID RD. |
| City, State, Zip | GRAND BLANC, MI 48439 |
| Country | US |
| FDA Owner/Operator Phone | 810-239-5553 |
| FDA Medical Specialty Code | CV - Cardiovascular |
| FDA Product Code | DTS |
| FDA Classification Name | SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS |
| FDA Device Classification Code | Standards |
| FDA Regulation Number | 870.4420 |
| FDA Common Generic Name | DISPOSABLE SUCTION |
| FDA Proprietary Device Name | DISPOSABLE SUCTION |
| FDA Owner / Operator Number | 9103660 |
| FDA Owner / Operator Name | TGI DIRECT |
| FDA Establishment Registration Number | 3006367242 |
| FDA Registered Establishment Name | TGI DIRECT |
| FDA Operation Code(s) |
RR - Repackager/Relabeller |
| FDA Listing Date | 06-25-07 |
| FDA Listing Status Code | Active |
| Differentiation | N/A |
| Keywords | N/A |
| Description | N/A |
| Brochure | N/A |
| Product Website | N/A |
Competitors of TGI DIRECT
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 | CALIFORNIA MEDICAL LABORATORIES, INC. 1570 SUNLAND LN. COSTA MESA, CA 92626 US 714-556-7365 / 714-556-7365 206 |
STANDARD: SMALL SUCTION WOUNDS | SUCTION WOUNDS |
| 2 | EDWARDS LIFESCIENCES RESEARCH MEDICAL 6864 SOUTH 300 WEST MIDVALE, UT 84047 US 949-250-2500 / 949-250-2698 |
SUCTION WANDS | CARDIAC SUCKER |
| 3 | GISH BIOMEDICAL, INC. 22942 ARROYO VISTA RANCHO SANTA MARGARITA, CA 92688 US 949-635-6200 / 949-635-6240 |
ROBISCEK INTRACARDIAC SUCTION WAND; | STERILE ROBISCEK INTRACARDIAC SUCTION WAND & FLEXIBLE SUCTION DEVICE |
| 4 | INTERNATIONAL BIOPHYSICS CORP. 2101-2 E. ST. ELMO SUITE 275 AUSTIN, TX 78744 US 512-326-3244 / 512-326-3244 |
IBC MINI SUCKER | SUCTION WAND |
| 5 | JOSTRA BENTLEY, INC. RD. 402 N. KM 1.4 INDUSTRIAL PARK ANASCO, PR 00610 US 49-747-8921-0 / 302-454-9959 |
DISPOSABLE SUCKER | DISPOSABLE SUCKER |
| 6 | MAQUET CARDIOPULMONARY AG HECHINGER STRASSE 38 HIRRLINGEN, 72145 GM 49-747-8921-0 / 49-747-8921151 |
MULTIPLE | SUCKERS |
| 7 | MEDTRONIC MEXICO, S. DE R.L. DE C.V. AVENIDA PASEO DEL CUCAPAH10510 PARQUE INDUSTRIAL EL LAGO TIJUANA, B.C., 22570 MX 763-514-4000 / 763-391-9030 |
DISPOSABLE SUCTION | DISPOSABLE SUCTION |
| 8 | MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. MINNEAPOLIS, MN 55432 US 763-514-4000 / 763-391-9030 |
DISPOSABLE SUCTION | DISPOSABLE SUCTION |
| 9 | NOVOSCI CORP. 2828 NORTH CRESCENT RIDGE DR. THE WOODLANDS, TX 77381 US 281-363-4949 / 281-363-4949 3364 |
MULTIPLE | CARDIOTOMY RETURN SUCKER |
| 10 | PEMCO, INC. 5663 BRECKSVILLE RD. INDEPENDENCE, OH 44131 US / 216-524-2990 |
PEMCO REUSABLE SUCTION PROBES, VARIOUS MODELS | SUCTION PROBE |
| 11 | PREMIER MEDICAL 10090 SANDMEYER LN. PHILADELPHIA, PA 19116 US 610-239-6000 / 610-239-6015 |
NONE | CARDIOPULMONARY BYPASS, CARDIOTOMY SUCTION TUBE |
| 12 | SORIN GROUP DEUTSCHLAND GMBH LINDBERGH STRASSE 25 MUNCHEN, 80939 GM 49-89-323010 / 49- 89-32301x152 |
MULTIPLE | VARIOUS |
| 13 | SORIN GROUP ITALIA S.R.L 86,VIA STATALE 12 NORD, MIRANDOLA(MO), 41037 IT 39-053-5 29811 / 39-053-529811 |
MULTIPLE | VARIOUS MODELS OF HAND-HELD INTRACARDIAC SUCKERS |
| 14 | TERUMO CARDIOVASCULAR SYSTEMS CORP. 6200 JACKSON RD. ANN ARBOR, MI 48103 US 800-283-7866 / 734-663-4145 6238 |
SUCTION DEVICES | SUCTION DEVICES |
| 15 | TERUMO CARDIOVASCULAR SYSTEMS CORP. 125 BLUE BALL RD. ELKTON, MD 21921 US 734-741-6238 / 800-283-7866 7420 |
MULTIPLE | SUCKERS |
| 16 | TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 28 HOWE ST. ASHLAND, MA 01721 US 734-741-6238 / 800-283-7866 7420 |
MULTIPLE | SUCKERS |
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