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BICARBONATE DIALYSATE CONCERTRATE,DRI-SATE MIXER
 Request for Information Form |
 Contact Information
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| Company Name | ROCKWELL MEDICAL TECHNOLOGIES |
| Address | 308 N. IOWA STREET |
| City, State, Zip | WASHINGTON, IA 52353 |
| Country | US |
| FDA Owner/Operator Phone | 248-960-9009 |
| FDA Medical Specialty Code | GU - Gastroenterology/Urology |
| FDA Product Code | KPO |
| FDA Classification Name | DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) |
| FDA Device Classification Code | Standards |
| FDA Regulation Number | 876.5820 |
| FDA Common Generic Name | BICARBONATE DIALYSATE CONCERTRATE,DRI-SATE MIXER FOR PREPARATION OF ACIDIFIED DI |
| FDA Proprietary Device Name | BICARBONATE DIALYSATE CONCERTRATE,DRI-SATE MIXER |
| FDA Owner / Operator Number | 9030991 |
| FDA Owner / Operator Name | ROCKWELL MEDICAL TECHNOLOGIES, INC. |
| FDA Establishment Registration Number | 1954315 |
| FDA Registered Establishment Name | ROCKWELL MEDICAL TECHNOLOGIES |
| FDA Operation Code(s) |
MM - Manufacturer |
| FDA Listing Date | 11-29-05 |
| FDA Listing Status Code | Active |
| Differentiation | N/A |
| Keywords | N/A |
| Description | N/A |
| Brochure | N/A |
| Product Website | N/A |
Competitors of ROCKWELL MEDICAL TECHNOLOGIES
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 | ACS DOBFAR INFO SA CASAI CAMPASCIO, 7748 SZ 41-81-8465833 / 201-261-7333 |
NXSTAGE PRIMIXED DIALYSATE | PREMIXED DIALYSATE |
| 2 | ADVANCED RENAL TECHNOLOGIES, INC. 40 LAKE BELLEVUE SUITE 100 BELLEVUE, WA 98005 US 425-453-8777 / 425-453-8777 |
DRYALYSATE CONCENTRATE | ACID CONCENTRATE FOR HEMODIALYSIS |
| 3 | APOTEX, INC. 380 ELGIN MILLS ROAD EAST RICHMOND HILL, ONTARIO, L4C 5H2 CA 416-749-9300 / 905-508-2396 |
NORMOCARB 35 | STERILE BICARBONATE RENAL DIALYSIS CONCENTRATE |
| 4 | B. BRAUN MEDIZINTECHNOLOGIE GMBH KATTENVENNER STR. 32 GLANDORF, DE-49219 GM 49-566-1711404 / 610-596-2536 |
NXSTAGE PREMIXED DIALYSATE | PREMIXED DIALYSATE |
| 5 | BAXTER CORPORATION 89 CENTRE ST. ALLISTON, L9R 1W7 CA 847-948-2000 / 847-473-6141 |
VARIOUS | HEMODIALYSIS CONCENTRATES |
| 6 | BAXTER HEALTHCARE CORPORATION U.S. HIGHWAY 221 NORTH (NORTH COVE) MARION, NC 28752 US 847-948-2000 / 847-473-6141 |
VARIOUS | HEMODIALYSIS CONCENTRATES |
| 7 | BAXTER HEALTHCARE CORPORATION - RENAL DIVISION 1620 WAUKEGAN ROAD BUILDING R MCGAW PARK, IL 60085 US 847-948-2000 / 847-473-6141 |
VARIOUS | HEMODIALYSIS CONCENTRATES |
| 8 | CENTURY PHARMACEUTICALS, INC. 10377 HAGUE RD. INDIANAPOLIS, IN 46256 US 317-849-4210 / 317-849-4210 |
VARIOUS DIALYSATE CONCENTRATES FOR HEMPDIALYSIS | |
| 9 | CHIEF MEDICAL SUPPLIES LTD 117, 3016 10TH AVENUE CALGARY, ALBERTA, T2A 6A3 CA 403-207-6034 / 973-652-5788 |
HEMODIALYSIS CONCENTRATE | HEMODIALYSIS CONCENTRATE |
| 10 | CLINICAL PHARMACIES, INC. 21622 SURVEYOR CIRCLE, #8-C HUNTINGTON BEACH, CA 92646 US 714-969-6818 / 714-969-5101 |
HEMODIALYSIS CONCENTRATES | HEMODIALYSIS CONCENTRATES |
| 11 | DIALYSIS SOLUTIONS, INC. 380 ELGIN MILLS RD. EAST RICHMOND HILL, ONTARIO, L4C 5H2 CA 905-669-3832 / 905-508-2396 |
NORMOCARB | STERILE BICARBONTAE RENAL DIALYSIS CONCENTRATE |
| 12 | DIASOL, INC. 13212 RAYMER ST. NORTH HOLLYWOOD, CA 91605 US 818-255-1800 / 818-255-1800 |
DIASOL | DIASOL CONCENTRATE SOLUTION |
| 13 | DI-CHEM CONCENTRATE, INC. 509 FISHING CREEK RD. LEWISBERRY, PA 17339 US 763-422-8311 / 763-422-8311 |
FRESENIUS DIALYSATE CONCENTRATE | DIALYSATE CONCENTRATE |
| 14 | DI-CHEM, INC. 12297 ENSIGN AVE. NORTH CHAMPLIN, MN 55316 US 763-422-8311 / 763-422-8311 |
VARIOUS CHEMICALS IN VARIOUS AMOUNTS | DIALYSATE ADDITIVES(LIQUID OR POWDER) |
| 15 | EDLAW PHARMACEUTICALS, INC. 195-B CENTRAL AVE. FARMINGDALE, NY 11735 US 631-454-6888 / 631-454-6888 |
CHEMICAL ADDITIVES/DIALYSATE CHEMICALS | |
| 16 | ENTRADA GROUP/NXSTAGE CARRETERA FRESNILLO A PLATEROS KM2 FRESNILLO ZACATECAS, 99059 MX 978-687-4700 / 978-687-4710 |
NXSTAGE PUREFLOW SL | DIALYSATE AND CONCENTRATE FOR HEMODIALYSIS |
| 17 | FRESENIUS MEDICAL CARE NORTH AMERICA 920 WINTER STREET WALTHAM, MA 02451 US 781-699-9000 / 781-699-9068 |
MULTIPLE | DIALYSIS CONCENTRATE |
| 18 | FRESENIUS MEDICAL CARE NORTH AMERICA 750 NORTH LALLENDORF RD. OREGON, OH 43616 US 781-699-9000 / 781-699-9068 |
MULTIPLE | DIALYSIS CONCENTRATE |
| 19 | FRESENIUS MEDICAL CARE NORTH AMERICA 28157 CEDAR PARK BLVD. PERRYSBURG, OH 43551 US 781-699-9000 / 781-699-9068 |
MULTIPLE | DIALYSIS CONCENTRATE |
| 20 | FRESENIUS MEDICAL CARE NORTH AMERICA 420 INDUSTRIAL DR. LIVINGSTON, CA 95334 US 781-699-9000 / 781-699-9068 |
MULTIPLE | DIALYSIS CONCENTRATE |
| 21 | FRESENIUS MEDICAL CARE NORTH AMERICA 5201 REGENT BLVD. IRVING, TX 75063 US 781-699-9000 / 781-699-9068 |
MULTIPLE | DIALYSIS CONCENTRATE |
| 22 | GAMBRO LUNDIA AB, SOLUTION DIV. MAGISTRATSVAGEN 16 LUND, SE-220-10 SW / 303-231-4094 |
MULTIPLE | DIALYSIS CONCENTRATE |
| 23 | GAMBRO RENAL PRODUCTS 1845 MASON AVE. DAYTONA BEACH, FL 32117 US / 303-231-4094 |
DRYAC AND PRISMASATE | VARIOUS TYPES OF DIALYSIS SOLUTIONS |
| 24 | GAMBRO RENAL PRODUCTS, INC. 14143 DENVER WEST PARKWAY LAKEWOOD, CO 80401 US / 303-542-5075 |
MULTIPLE | DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) |
| 25 | HAEMONETICS CORP. 155 MEDICAL SCIENCE DR. UNION, SC 29379 US 781-356-9488 / 864-466-4847 |
RENASOL | DIALYSATE CONCENTRATE |
| 26 | HAEMOTEC INC. 383, JOSEPH-CARRIER VAUDREUIL-DORLON, QUEBEC, J7V 5V5 CA 781-699-9000 / 781-699-9068 |
MULTIPLE | DIALYSIS CONCENTRATE |
| 27 | IVEX PHARMACEUTICALS LIMITED OLD BELFAST ROAD, MILLBROOK LARNE, BT40 2SH UK 303-231-4718 / 303-231-4718 |
NXSTAGE PREMIXED DIALYSATE | PREMIXED DIALYSATE |
| 28 | MINNTECH CORP. 14605 28TH AVE. NORTH MINNEAPOLIS, MN 55447 US 763-553-3300 / 763-551-2668 |
HEMODIALYSIS CONCENTRATE | HEMODIALYSIS CONCENTRATE |
| 29 | NXSTAGE MEDICAL, INC. 439 SOUTH UNION ST., 5TH FLOOR LAWRENCE, MA 01843 US 978-687-4700 / 978-687-4710 |
NXSTAGE PUREFLOW SL | DIALYSATE AND CONCENTRATE FOR HEMODIALYSIS |
| 30 | PISA FARMACEUTICA MEXICANA CALLE 7 N0. 1398 ZONA INDUSTRIAL GUADALAJARA, JALISCO, C.P.44940 MX 52-333-6782690 / 978-772-3552 |
PUREFLOW PREMIXED DIALYSATE | PREMIXED DIALYSATE |
| 31 | RIM DIRECT (CHINA) METAL WORKS COMPANY LTD. NO. 6 HUAN BOA YUAN TONG JIANG ROAD, CHANGZHOU JIANGSU, 213033 CH 828-859-2000 / 619-517-1762 |
NXSTAGE PREMIXED DIALYSATE | PREMIXED DIALYSATE |
| 32 | ROCKWELL MEDICAL TECHNOLOGIES, INC. 4051 FREEPORT PKWY. SUITE 100 GRAPEVINE, TX 76099 US 248-960-9009 / 248-960-9009 |
HEMODIALYSIS CONCENTRATE SOLUTIONS & POWDERS | HEMODIALYSIS CONCENTRATE SOLUTIONS & POWDERS |
| 33 | ROCKWELL MEDICAL TECHNOLOGIES, INC. 30142 WIXOM RD. WIXOM, MI 48393 US 248-960-9009 / 248-960-9009 |
HEMODIALYSIS CONCENTRATE SOLUTIONS & POWDERS | HEMODIALYSIS CONCENTRATE SOLUTIONS & POWDERS |
| 34 | ROCKWELL MEDICAL TECHNOLOGIES, INC. 604 HIGH TECH CT. GREER, SC 29650 US 248-960-9009 / 248-960-9009 |
HEMODIALYSIS CONCENTRATE SOLUTIONS; POWDERS | HEMODIALYSIS CONCENTRATE SOLUTIONS AND POWDERS |
| 35 | SORB TECHNOLOGY, INC. 3631 S.W. 54TH ST. OKLAHOMA CITY, OK 73119 US 724-772-6900 140 / 405-682-1993 13 |
SORBIO, DRY ACETATE ADDITIVE, INFUSATE | DIALYSATE CONCENTRATES, POWDERED |
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