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Sign in to claim this brandGambro, Inc.
US
Last updated May 23, 2026
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Catalogue (95)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Prismaflex | 5.XX | FDA UDI | Class II | Unknown |
| Mars Treatment Kit | 800480 | FDA UDI | Class II | Unknown |
| Mars Treatment Kit Type 1116/1 - X-Mars Us | 800541 | FDA UDI | Class II | Active |
| Prismaflex | 7.21 | FDA UDI | Class II | Unknown |
| Prismaflex | 7.20 | FDA UDI | Class II | Active |
| Ak 98 | 955607 | FDA UDI | Class II | Active |
| MARS Monitor | 800437 | FDA UDI | Class II | Active |
| Prismaflex | 7.XX | FDA UDI | Class II | Active |
| Gambro-Engstrom Erica Iv Respirator | K872482 | FDA 510(k) | Class II | Active |
| Gambro Peritoneal Dialysis Fluid Lines | K811294 | FDA 510(k) | Class II | Active |
| Gambro Alwall Gfs 11, 12, Plus 12 Hollow Fiber Dialy | K892523 | FDA 510(k) | Class II | Active |
| Gambro Lundia Fiber | K800336 | FDA 510(k) | Class II | Active |
| Lundia 10-2-L Parallel Plate Hemodialy | K832894 | FDA 510(k) | Class II | Active |
| Crafton Arthroscopy Pump Ap-10 | K823848 | FDA 510(k) | Class II | Active |
| Gambro Peritoneal Dialysis Monitor | K802831 | FDA 510(k) | Class II | Active |
| Gambro Pump Console Csl | K822068 | FDA 510(k) | Class II | Active |
| Lundia 10-5-L Parralle Flow Dialyzer | K823791 | FDA 510(k) | Class II | Active |
| Gambro Fluid Control Monitor Fcm 10-1 | K864094 | FDA 510(k) | Class II | Active |
| Thermostatic Water Mixing Valve Twv10 | K822874 | FDA 510(k) | Class II | Active |
| Fiber Hemofilters Fh55-Fh77 & 88 | K840720 | FDA 510(k) | Class II | Active |
| Gambro Lundia Plate Dialyzer | K792611 | FDA 510(k) | Class II | Active |
| Gambro Hemofreeze-Bag | K801082 | FDA 510(k) | Class II | Active |
| Gambro G Series Blood Line Sets For Hem. | K801016 | FDA 510(k) | Class II | Active |
| Oxygenator 10 | K823343 | FDA 510(k) | Class II | Active |
| Lundia Plate Disp. | K800424 | FDA 510(k) | Class II | Active |
| Prismaflex System, Version 3.20 | K072093 | FDA 510(k) | Class II | Active |
| Prisma M60/M100 Sets | K032431 | FDA 510(k) | Class II | Active |
| Gambro Bicarbonate Monitor Bcm 10-2 | K864083 | FDA 510(k) | Class II | Active |
| Coil Machine Adapter | K760725 | FDA 510(k) | Class II | Active |
| Dialyzer, Disp., Coil, Lundia | K781102 | FDA 510(k) | Class II | Active |
| Gf-120-L Dialyzer | K801370 | FDA 510(k) | Class II | Active |
| Gambro Adsorba 150c | K873643 | FDA 510(k) | Class II | Active |
| Blood Line Sets For Hemofiltration | K830677 | FDA 510(k) | Class II | Active |
| Gambro Polyflux 130 And 160 Hemodialyzer | K871108 | FDA 510(k) | Class II | Active |
| Engstrom Eliza + Co2 Analyzer | K890112 | FDA 510(k) | Class II | Active |
| Gambro Pulsatile Monitor Plm 10-200 | K842503 | FDA 510(k) | Class II | Active |
| Ultrafiltration Monitor Ufm-10-2 | K830596 | FDA 510(k) | Class II | Active |
| Gambro Lundia Coil Dialyzer | K800174 | FDA 510(k) | Class II | Active |
| Gambro Plasmafiltration System | K850621 | FDA 510(k) | U | Active |
| Gambro Ultrasonic Blood Level Detector Uld 10-200 | K860076 | FDA 510(k) | Class II | Active |
| Gambro Bicarbonate Monitor Bcm 10-3 | K896758 | FDA 510(k) | Class II | Active |
| Gambro Lundia Pro 3 & 5 Dialyzer | K853406 | FDA 510(k) | Class II | Active |
| Blood Concentrator 140 | K840543 | FDA 510(k) | Class II | Active |
| Gambro Lundia Ic-6h Parallel Plate Dialyzer | K900918 | FDA 510(k) | Class II | Active |
| Gambro Water Purification Monitor Wrd | K811678 | FDA 510(k) | Class II | Active |
| Lundia 10-3-L Parallel Flow Dialyzer | K831338 | FDA 510(k) | Class II | Active |
| Gambro Ak-10 Dialysis System For High Flows | K896757 | FDA 510(k) | Class II | Active |
| Gambro Alwall Gfe 11 & 15 Hollow Fiber Dialyzers | K880083 | FDA 510(k) | Class II | Active |
| Gambro Pressure Monitor Guards | K851230 | FDA 510(k) | Class II | Active |
| Gambro Fiber Hemofilters Fh 22/66 Dispos Tube Sets | K860938 | FDA 510(k) | Class II | Active |
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