No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00850015518072 | Locator AKS-1 | NaviCam Capsule Endoscope System with NaviCam Stomach Capsule; NaviCam Stomach System. | QKZ | Magnetically Maneuvered Capsule Endoscopy System | 2 | NaviCam Stomach System | |
2 | 00850015518232 | Combo | FFX | System, Gastrointestinal Motility (Electrical) | IntraMarX 3D | |||
3 | 00850015518164 | AGIROMC2-1-O/1 | AGIROMC2-1-O/1 | The IntraMarX 3D Radiopaque Markers can be used for the diagnosis of many GI con The IntraMarX 3D Radiopaque Markers can be used for the diagnosis of many GI conditions, including chronic constipation, colonic inertia, hypomotility and outlet delay and bowel obstruction. Each of the IntraMarX 3D capsules contains 24 tiny radiopaque rings within the capsule shell. The capsule is swallowed by the patient under the direction of physician. As this capsule moves through the digestive system, the capsule shell will dissolve and leave the rings in the GI tract of the patient; which will show up later during an x-ray scan. Five days after swallowing the capsule, a single x-ray scan of the abdomen will be taken to see the location of the rings and how many are left in the GI tract of the patient. The physician will make evaluations based on the rings remaining and make a diagnosis of GI conditions of the patient. | FFX | System, Gastrointestinal Motility (Electrical) | 2 | IntraMarX 3D |
4 | 00850015518157 | AGIROMC2-1-D/1 | AGIROMC2-1-D/1 | The IntraMarX 3D Radiopaque Markers can be used for the diagnosis of many GI con The IntraMarX 3D Radiopaque Markers can be used for the diagnosis of many GI conditions, including chronic constipation, colonic inertia, hypomotility and outlet delay and bowel obstruction. Each of the IntraMarX 3D capsules contains 24 tiny radiopaque rings within the capsule shell. The capsule is swallowed by the patient under the direction of physician. As this capsule moves through the digestive system, the capsule shell will dissolve and leave the rings in the GI tract of the patient; which will show up later during an x-ray scan. Five days after swallowing the capsule, a single x-ray scan of the abdomen will be taken to see the location of the rings and how many are left in the GI tract of the patient. The physician will make evaluations based on the rings remaining and make a diagnosis of GI conditions of the patient. | FFX | System, Gastrointestinal Motility (Electrical) | 2 | IntraMarX 3D |
5 | 00850015518201 | Controller/NaviEC-1000 | Controller. The NaviCam Capsule Endoscope System with NaviCam Stomach Capsule (“ Controller. The NaviCam Capsule Endoscope System with NaviCam Stomach Capsule (“NaviCam Stomach System” in short), is a novel endoscopic capsule imaging system intended to obtain images of the stomach. It differs from passive capsule endoscopy systems in that it uses magnetic fields to allow the position of the capsule to be controlled by an operator. | QKZ | Magnetically Maneuvered Capsule Endoscopy System | 2 | NaviCam Capsule Endoscope System | |
6 | 00850015518195 | Stomach Capsule/AKEM-11SW | The NaviCam Capsule Endoscope System with NaviCam Stomach Capsule (“NaviCam Stom The NaviCam Capsule Endoscope System with NaviCam Stomach Capsule (“NaviCam Stomach System” in short), is a novel endoscopic capsule imaging system intended to obtain images of the stomach. It differs from passive capsule endoscopy systems in that it uses magnetic fields to allow the position of the capsule to be controlled by an operator. | QKZ | Magnetically Maneuvered Capsule Endoscopy System | 2 | NaviCam Capsule Endoscope System | |
7 | 00850015518188 | Recorder/AKR-1 | DATA RECORDER. The NaviCam Capsule Endoscope System with NaviCam Stomach Capsule DATA RECORDER. The NaviCam Capsule Endoscope System with NaviCam Stomach Capsule (“NaviCam Stomach System” in short), is a novel endoscopic capsule imaging system intended to obtain images of the stomach. It differs from passive capsule endoscopy systems in that it uses magnetic fields to allow the position of the capsule to be controlled by an operator. | QKZ | Magnetically Maneuvered Capsule Endoscopy System | 2 | NaviCam Capsule Endoscope System | |
8 | 00850015518027 | AGIROMC1-1(TC) | AGIROMC1-1(TC) | The IntraMarX capsule can be used for the diagnosis of many GI conditions, inclu The IntraMarX capsule can be used for the diagnosis of many GI conditions, including chronic constipation, colonic inertia, hypomotility and outlet delay. Each of the IntraMarX capsules contains 24 tiny radiopaque rings within the capsule shell. The capsule is swallowed by the patient under the direction of physician. As this capsule moves through the digestive system, the capsule shell will dissolve and leave the rings in the GI tract of the patient; which will show up later during an X-ray scan. Five days after swallowing the capsule, a single scan of the abdomen will be taken to see the location of the rings and how many are left in the GI tract of the patient. The physician will make evaluations based on the rings remaining and make a diagnosis of GI conditions of the patient. | FFX | System, Gastrointestinal Motility (Electrical) | IntraMarX Radiopaque Markers | |
9 | 00850015518010 | AGIROMC1-1(DD) | AGIROMC1-1(DD) | The IntraMarX capsule can be used for the diagnosis of many GI conditions, inclu The IntraMarX capsule can be used for the diagnosis of many GI conditions, including chronic constipation, colonic inertia, hypomotility and outlet delay. Each of the IntraMarX capsules contains 24 tiny radiopaque rings within the capsule shell. The capsule is swallowed by the patient under the direction of physician. As this capsule moves through the digestive system, the capsule shell will dissolve and leave the rings in the GI tract of the patient; which will show up later during an X-ray scan. Five days after swallowing the capsule, a single scan of the abdomen will be taken to see the location of the rings and how many are left in the GI tract of the patient. The physician will make evaluations based on the rings remaining and make a diagnosis of GI conditions of the patient. | FFX | System, Gastrointestinal Motility (Electrical) | IntraMarX Radiopaque Markers | |
10 | 00850015518003 | AGIROMC1-1(R) | AGIROMC1-1(R) | The IntraMarX capsule can be used for the diagnosis of many GI conditions, inclu The IntraMarX capsule can be used for the diagnosis of many GI conditions, including chronic constipation, colonic inertia, hypomotility and outlet delay. Each of the IntraMarX capsules contains 24 tiny radiopaque rings within the capsule shell. The capsule is swallowed by the patient under the direction of physician. As this capsule moves through the digestive system, the capsule shell will dissolve and leave the rings in the GI tract of the patient; which will show up later during an X-ray scan. Five days after swallowing the capsule, a single scan of the abdomen will be taken to see the location of the rings and how many are left in the GI tract of the patient. The physician will make evaluations based on the rings remaining and make a diagnosis of GI conditions of the patient. | FFX | System, Gastrointestinal Motility (Electrical) | IntraMarX Radiopaque Markers | |
11 | 00850015518140 | AGIROMC-1-TC/1 | AGIROMC-1-TC/1 | The IntraMarX capsule can be used for the diagnosis of many GI conditions, inclu The IntraMarX capsule can be used for the diagnosis of many GI conditions, including chronic constipation, colonic inertia, hypomotility and outlet delay. Each of the IntraMarX capsules contains 24 tiny radiopaque rings within the capsule shell. The capsule is swallowed by the patient under the direction of physician. As this capsule moves through the digestive system, the capsule shell will dissolve and leave the rings in the GI tract of the patient; which will show up later during an X-ray scan. Five days after swallowing the capsule, a single scan of the abdomen will be taken to see the location of the rings and how many are left in the GI tract of the patient. The physician will make evaluations based on the rings remaining and make a diagnosis of GI conditions of the patient. | FFX | System, Gastrointestinal Motility (Electrical) | 2 | IntraMarX |
12 | 00850015518133 | AGIROMC1-1-DD/1 | AGIROMC1-1-DD/1 | The IntraMarX capsule can be used for the diagnosis of many GI conditions, inclu The IntraMarX capsule can be used for the diagnosis of many GI conditions, including chronic constipation, colonic inertia, hypomotility and outlet delay. Each of the IntraMarX capsules contains 24 tiny radiopaque rings within the capsule shell. The capsule is swallowed by the patient under the direction of physician. As this capsule moves through the digestive system, the capsule shell will dissolve and leave the rings in the GI tract of the patient; which will show up later during an X-ray scan. Five days after swallowing the capsule, a single scan of the abdomen will be taken to see the location of the rings and how many are left in the GI tract of the patient. The physician will make evaluations based on the rings remaining and make a diagnosis of GI conditions of the patient. | FFX | System, Gastrointestinal Motility (Electrical) | 2 | IntraMarX |
13 | 00850015518126 | AGIROMC1-1-R/1 | AGIROMC1-1-R/1 | The IntraMarX capsule can be used for the diagnosis of many GI conditions, inclu The IntraMarX capsule can be used for the diagnosis of many GI conditions, including chronic constipation, colonic inertia, hypomotility and outlet delay. Each of the IntraMarX capsules contains 24 tiny radiopaque rings within the capsule shell. The capsule is swallowed by the patient under the direction of physician. As this capsule moves through the digestive system, the capsule shell will dissolve and leave the rings in the GI tract of the patient; which will show up later during an X-ray scan. Five days after swallowing the capsule, a single scan of the abdomen will be taken to see the location of the rings and how many are left in the GI tract of the patient. The physician will make evaluations based on the rings remaining and make a diagnosis of GI conditions of the patient. | FFX | System, Gastrointestinal Motility (Electrical) | 2 | IntraMarX |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 04260167483597 | RFG-1286-EAN | ESO Catheter, RFG | ManoScan | COVIDIEN LP | |
2 | 04260167482989 | RFG-3890-EAN | ESO Catheter, RFG | ManoScan | GIVEN IMAGING, INC. | |
3 | 04260167482637 | RFG-8001 | ESO 3D Catheter | ManoScan | COVIDIEN LP | |
4 | 04260167482569 | RFG-1286 | ESO Catheter, RFG | ManoScan | COVIDIEN LP | |
5 | 04260167482552 | RFG-2192 | AR Catheter, Regular | ManoScan | COVIDIEN LP | |
6 | 04260167482545 | RFG-2195 | AR Catheter, Small | ManoScan | COVIDIEN LP | |
7 | 04260167482538 | RFG-3885 | AR 3D Probe | ManoScan | COVIDIEN LP | |
8 | 04260167482521 | RFG-3886 | ESO Catheter, SD Small | ManoScan | COVIDIEN LP | |
9 | 04260167482514 | RFG-3887 | ESO Catheter, SD Regular | ManoScan | COVIDIEN LP | |
10 | 04260167482507 | RFG-3890 | ESO Z Catheter | ManoScan | COVIDIEN LP | |
11 | 04260167482491 | RFG-8000-15 | ESO With Extended Tip | ManoScan | COVIDIEN LP | |
12 | 04260167482484 | 1286 | 1286 | ESO Catheter | ManoScan | GIVEN IMAGING, INC. |
13 | 04260167482477 | 2192 | 2192 | AR Catheter, Regular | ManoScan | GIVEN IMAGING, INC. |
14 | 04260167482460 | 2195 | 2195 | AR Catheter, Small | ManoScan | GIVEN IMAGING, INC. |
15 | 04260167482453 | 3886 | 3886 | ESO Catheter, SD Small | ManoScan | GIVEN IMAGING, INC. |
16 | 04260167482446 | 3890 | 3890 | ESO Z Catheter | ManoScan | GIVEN IMAGING, INC. |
17 | 04260167482439 | 800015 | 800015 | ESO With Extended Tip | ManoScan | GIVEN IMAGING, INC. |
18 | 04260167482422 | FGS-8001 | FGS-8001 | ESO 3D Catheter | ManoScan | GIVEN IMAGING, INC. |
19 | 04260167482262 | MSS-4360 | Assy, Retail Box of 20, ManoShield SD | ManoScan | COVIDIEN LP | |
20 | 04260167482248 | MSS-3599 | Assy, Retail Box of 10, ManoShield AR | ManoScan | COVIDIEN LP | |
21 | 04260167482200 | MSS-2155 | Assy, Retail Box of 20, ManoShield EG | ManoScan | COVIDIEN LP | |
22 | 04260167480961 | 3887 | 3887 | ESO Catheter, SD Regular | ManoScan | GIVEN IMAGING, INC. |
23 | 04260167480954 | 3885 | AR 3D Probe | ManoScan | COVIDIEN LP | |
24 | 00850015518232 | Combo | IntraMarX 3D | ANX ROBOTICA CORP | ||
25 | 00850015518171 | AGIROMIC2-1-TC/1 | AGIROMIC2-1-TC/1 | The IntraMarX 3D Radiopaque Markers can be used for the diagnosis of many GI con The IntraMarX 3D Radiopaque Markers can be used for the diagnosis of many GI conditions, including chronic constipation, colonic inertia, hypomotility and outlet delay and bowel obstruction. Each of the IntraMarX 3D capsules contains 24 tiny radiopaque rings within the capsule shell. The capsule is swallowed by the patient under the direction of physician. As this capsule moves through the digestive system, the capsule shell will dissolve and leave the rings in the GI tract of the patient; which will show up later during an x-ray scan. Five days after swallowing the capsule, a single x-ray scan of the abdomen will be taken to see the location of the rings and how many are left in the GI tract of the patient. The physician will make evaluations based on the rings remaining and make a diagnosis of GI conditions of the patient. | IntraMarX 3D | ANX ROBOTICA CORP |
26 | 00850015518164 | AGIROMC2-1-O/1 | AGIROMC2-1-O/1 | The IntraMarX 3D Radiopaque Markers can be used for the diagnosis of many GI con The IntraMarX 3D Radiopaque Markers can be used for the diagnosis of many GI conditions, including chronic constipation, colonic inertia, hypomotility and outlet delay and bowel obstruction. Each of the IntraMarX 3D capsules contains 24 tiny radiopaque rings within the capsule shell. The capsule is swallowed by the patient under the direction of physician. As this capsule moves through the digestive system, the capsule shell will dissolve and leave the rings in the GI tract of the patient; which will show up later during an x-ray scan. Five days after swallowing the capsule, a single x-ray scan of the abdomen will be taken to see the location of the rings and how many are left in the GI tract of the patient. The physician will make evaluations based on the rings remaining and make a diagnosis of GI conditions of the patient. | IntraMarX 3D | ANX ROBOTICA CORP |
27 | 00850015518157 | AGIROMC2-1-D/1 | AGIROMC2-1-D/1 | The IntraMarX 3D Radiopaque Markers can be used for the diagnosis of many GI con The IntraMarX 3D Radiopaque Markers can be used for the diagnosis of many GI conditions, including chronic constipation, colonic inertia, hypomotility and outlet delay and bowel obstruction. Each of the IntraMarX 3D capsules contains 24 tiny radiopaque rings within the capsule shell. The capsule is swallowed by the patient under the direction of physician. As this capsule moves through the digestive system, the capsule shell will dissolve and leave the rings in the GI tract of the patient; which will show up later during an x-ray scan. Five days after swallowing the capsule, a single x-ray scan of the abdomen will be taken to see the location of the rings and how many are left in the GI tract of the patient. The physician will make evaluations based on the rings remaining and make a diagnosis of GI conditions of the patient. | IntraMarX 3D | ANX ROBOTICA CORP |
28 | 00850015518140 | AGIROMC-1-TC/1 | AGIROMC-1-TC/1 | The IntraMarX capsule can be used for the diagnosis of many GI conditions, inclu The IntraMarX capsule can be used for the diagnosis of many GI conditions, including chronic constipation, colonic inertia, hypomotility and outlet delay. Each of the IntraMarX capsules contains 24 tiny radiopaque rings within the capsule shell. The capsule is swallowed by the patient under the direction of physician. As this capsule moves through the digestive system, the capsule shell will dissolve and leave the rings in the GI tract of the patient; which will show up later during an X-ray scan. Five days after swallowing the capsule, a single scan of the abdomen will be taken to see the location of the rings and how many are left in the GI tract of the patient. The physician will make evaluations based on the rings remaining and make a diagnosis of GI conditions of the patient. | IntraMarX | ANX ROBOTICA CORP |
29 | 00850015518133 | AGIROMC1-1-DD/1 | AGIROMC1-1-DD/1 | The IntraMarX capsule can be used for the diagnosis of many GI conditions, inclu The IntraMarX capsule can be used for the diagnosis of many GI conditions, including chronic constipation, colonic inertia, hypomotility and outlet delay. Each of the IntraMarX capsules contains 24 tiny radiopaque rings within the capsule shell. The capsule is swallowed by the patient under the direction of physician. As this capsule moves through the digestive system, the capsule shell will dissolve and leave the rings in the GI tract of the patient; which will show up later during an X-ray scan. Five days after swallowing the capsule, a single scan of the abdomen will be taken to see the location of the rings and how many are left in the GI tract of the patient. The physician will make evaluations based on the rings remaining and make a diagnosis of GI conditions of the patient. | IntraMarX | ANX ROBOTICA CORP |
30 | 00850015518126 | AGIROMC1-1-R/1 | AGIROMC1-1-R/1 | The IntraMarX capsule can be used for the diagnosis of many GI conditions, inclu The IntraMarX capsule can be used for the diagnosis of many GI conditions, including chronic constipation, colonic inertia, hypomotility and outlet delay. Each of the IntraMarX capsules contains 24 tiny radiopaque rings within the capsule shell. The capsule is swallowed by the patient under the direction of physician. As this capsule moves through the digestive system, the capsule shell will dissolve and leave the rings in the GI tract of the patient; which will show up later during an X-ray scan. Five days after swallowing the capsule, a single scan of the abdomen will be taken to see the location of the rings and how many are left in the GI tract of the patient. The physician will make evaluations based on the rings remaining and make a diagnosis of GI conditions of the patient. | IntraMarX | ANX ROBOTICA CORP |
31 | 00850015518027 | AGIROMC1-1(TC) | AGIROMC1-1(TC) | The IntraMarX capsule can be used for the diagnosis of many GI conditions, inclu The IntraMarX capsule can be used for the diagnosis of many GI conditions, including chronic constipation, colonic inertia, hypomotility and outlet delay. Each of the IntraMarX capsules contains 24 tiny radiopaque rings within the capsule shell. The capsule is swallowed by the patient under the direction of physician. As this capsule moves through the digestive system, the capsule shell will dissolve and leave the rings in the GI tract of the patient; which will show up later during an X-ray scan. Five days after swallowing the capsule, a single scan of the abdomen will be taken to see the location of the rings and how many are left in the GI tract of the patient. The physician will make evaluations based on the rings remaining and make a diagnosis of GI conditions of the patient. | IntraMarX Radiopaque Markers | ANX ROBOTICA CORP |
32 | 00850015518010 | AGIROMC1-1(DD) | AGIROMC1-1(DD) | The IntraMarX capsule can be used for the diagnosis of many GI conditions, inclu The IntraMarX capsule can be used for the diagnosis of many GI conditions, including chronic constipation, colonic inertia, hypomotility and outlet delay. Each of the IntraMarX capsules contains 24 tiny radiopaque rings within the capsule shell. The capsule is swallowed by the patient under the direction of physician. As this capsule moves through the digestive system, the capsule shell will dissolve and leave the rings in the GI tract of the patient; which will show up later during an X-ray scan. Five days after swallowing the capsule, a single scan of the abdomen will be taken to see the location of the rings and how many are left in the GI tract of the patient. The physician will make evaluations based on the rings remaining and make a diagnosis of GI conditions of the patient. | IntraMarX Radiopaque Markers | ANX ROBOTICA CORP |
33 | 00850015518003 | AGIROMC1-1(R) | AGIROMC1-1(R) | The IntraMarX capsule can be used for the diagnosis of many GI conditions, inclu The IntraMarX capsule can be used for the diagnosis of many GI conditions, including chronic constipation, colonic inertia, hypomotility and outlet delay. Each of the IntraMarX capsules contains 24 tiny radiopaque rings within the capsule shell. The capsule is swallowed by the patient under the direction of physician. As this capsule moves through the digestive system, the capsule shell will dissolve and leave the rings in the GI tract of the patient; which will show up later during an X-ray scan. Five days after swallowing the capsule, a single scan of the abdomen will be taken to see the location of the rings and how many are left in the GI tract of the patient. The physician will make evaluations based on the rings remaining and make a diagnosis of GI conditions of the patient. | IntraMarX Radiopaque Markers | ANX ROBOTICA CORP |
34 | 00827002249745 | G24974 | SOM-18-L-LEHMAN-NG | Lehman Manometry Catheter | Lehman | COOK INCORPORATED |
35 | 00827002249721 | G24972 | SOM-18-S-LEHMAN-NG | Lehman Manometry Catheter | Lehman | COOK INCORPORATED |
36 | 00827002219922 | G21992 | BMCG-1 | Biliary Motility Catheter Guided | Cook | COOK INCORPORATED |
37 | 00816734023112 | ULTSYS-II | ULTSYS-II | inSIGHT Ultima Base System | inSIGHT Ultima | DIVERSATEK HEALTHCARE, INC. |
38 | 00816734023105 | ULTCART-II | ULTCART-II | inSIGHT Ultima Base Cart System | inSIGHT Ultima | DIVERSATEK HEALTHCARE, INC. |
39 | 00816734023099 | PRIZMSYS-II | PRIZMSYS-II | PriZm Base System | PriZm | DIVERSATEK HEALTHCARE, INC. |
40 | 00816734023075 | PRIZMCART-II | PRIZMCART-II | PriZm Base Cart System | PriZm | DIVERSATEK HEALTHCARE, INC. |
41 | 00816734023068 | H20-4500 | H20-4500 | PriZm® Central Unit | PriZm | DIVERSATEK HEALTHCARE, INC. |
42 | 00816734023013 | H12R-7210 | H12R-7210 | Ultima Cable for HRCA Manometry Probe (Lemo Connector) | Ultima | DIVERSATEK HEALTHCARE, INC. |
43 | 00816734023006 | H12R-7110 | H12R-7110 | Ultima Cable for High Resolution Manometry Probe | Ultima | DIVERSATEK HEALTHCARE, INC. |
44 | 00816734022993 | H20-4000 | H20-4000 | PriZm® Central Unit | PriZm | DIVERSATEK HEALTHCARE, INC. |
45 | 00816734022924 | HRAM-200-17-KIT | HRAM-200-17-KIT | Zvu® HRAM Starter Kit | Zvu® | DIVERSATEK HEALTHCARE, INC. |
46 | 00816734022917 | HRIM-201-12-KIT | HRIM-201-12-KIT | Zvu® HRiM Probe Kit | Zvu® | DIVERSATEK HEALTHCARE, INC. |
47 | 00816734022894 | H12R-7610 | H12R-7610 | Replacement Cable for Zvu® HRiM and HRaM Probes | Zvu® | DIVERSATEK HEALTHCARE, INC. |
48 | 00816734022887 | PRIZMSYS | PRIZMSYS | PriZm Base System | PriZm | DIVERSATEK HEALTHCARE, INC. |
49 | 00816734022870 | PRIZMCART | PRIZMCART | PriZm Base Cart System | PriZm | DIVERSATEK HEALTHCARE, INC. |
50 | 00816734022863 | HRAM-PROC-10 | HRAM-PROC-10 | Zvu® Anorectal Manometry Procedure Kit | Zvu® | DIVERSATEK HEALTHCARE, INC. |