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 | 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. | FFX | System, Gastrointestinal Motility (Electrical) | 2 | 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 | 00610858081306 | Combo Pak | Sitzmarks Radiopaque Markers | KONSYL PHARMACEUTICALS, INC. | ||
2 | 00610858081139 | Combo Pak | Sitzmarks Radiopaque Markers | KONSYL PHARMACEUTICALS, INC. | ||
3 | 00610858081122 | Tri-Chamber | Sitzmarks Radiopaque Markers | KONSYL PHARMACEUTICALS, INC. | ||
4 | 00610858081115 | Double D | Sitzmarks Radiopaque Markers | KONSYL PHARMACEUTICALS, INC. | ||
5 | 00610858081108 | Round Hollow | Sitzmarks Radiopaque Markers | KONSYL PHARMACEUTICALS, INC. | ||
6 | 00610858081092 | Tri-Chamber | Sitzmarks Radiopaque Markers | KONSYL PHARMACEUTICALS, INC. | ||
7 | 00610858081085 | Double D | Sitzmarks Radiopaque Markers | KONSYL PHARMACEUTICALS, INC. | ||
8 | 00610858081078 | Round Hollow | Sitzmarks Radiopaque Markers | KONSYL PHARMACEUTICALS, INC. | ||
9 | 00610858081023 | Tri-Chamber | Sitzmarks Radiopaque Markers | KONSYL PHARMACEUTICALS, INC. | ||
10 | 00610858081016 | Double D | Sitzmarks Radiopaque Markers | KONSYL PHARMACEUTICALS, INC. | ||
11 | 00610858081009 | Round Hollow | Sitzmarks Radiopaque Markers | KONSYL PHARMACEUTICALS, INC. | ||
12 | 00006784675410 | CBS6P | Non Lotex Balloon (400 mL) - POLYISOPRENE | Mui Scientific | H & A MUI ENTERPRISES INC | |
13 | 00006784673928 | C7-R1-1003 | CUSTOMIZED 1ch Anorectal Catheter With Balloon | Mui Scientific | H & A MUI ENTERPRISES INC | |
14 | 00006784672921 | SPR1R(150) | Catheter Single-Use Anorectal Expulsion | Mui Scientific | H & A MUI ENTERPRISES INC | |
15 | B019ZPNBS500 | ZPN-BS-50 | ZPN-BS-50 | Non-Infused Single-Use Z/pH Probe (Internal Reference), Single pH (Esophageal) | Sandhill Scientific | DIVERSATEK HEALTHCARE, INC. |
16 | B019ZPNBS46E0 | ZPN-BS-46E | ZPN-BS-46E | Non-Infused Single-Use Z/pH Probe (External Reference), Single pH (Esophageal) | Sandhill Scientific | DIVERSATEK HEALTHCARE, INC. |
17 | B019ZVU20160 | ZVU-2016 | ZVU-2016 | ZVU® Advanced GI Diagnostic Software | Sandhill Scientific | DIVERSATEK HEALTHCARE, INC. |
18 | B019ZPNBS460 | ZPN-BS-46 | ZPN-BS-46 | Non-Infused Single-Use Z/pH Probe (Internal Reference), Single pH (Esophageal) | Sandhill Scientific | DIVERSATEK HEALTHCARE, INC. |
19 | B019ZPNBG07E0 | ZPN-BG-07E | ZPN-BG-07E | Non-Infused Single-Use Z/pH Probe (External Reference), Dual pH (Gastric & Esophageal) | Sandhill Scientific | DIVERSATEK HEALTHCARE, INC. |
20 | B019ZPNBG070 | ZPN-BG-07 | ZPN-BG-07 | Non-Infused Single-Use Z/pH Probe (Internal Reference), Dual pH (Gastric and Esophageal) | Sandhill Scientific | DIVERSATEK HEALTHCARE, INC. |
21 | B019ZPIBS460 | ZPI-BS-46 | ZPI-BS-46 | Infused Single-Use Z/pH Probe (Internal Reference), Single pH (Esophageal) with Infused Single-Use Z/pH Probe (Internal Reference), Single pH (Esophageal) with LES Locator, Locator Port 6cm | Sandhill Scientific | DIVERSATEK HEALTHCARE, INC. |
22 | B019ZPIBG520 | ZPI-BG-52 | ZPI-BG-52 | Infused Single-Use Z/pH Probe (Internal Reference), Dual pH (Gastric and Esophag Infused Single-Use Z/pH Probe (Internal Reference), Dual pH (Gastric and Esophageal), Locator Port 6cm | Sandhill Scientific | DIVERSATEK HEALTHCARE, INC. |
23 | B019ZINBS510 | ZIN-BS-51 | ZIN-BS-51 | Non-Infused Single-Use Z/pH Probe (Internal Reference), Single pH (Esophageal) | Sandhill Scientific | DIVERSATEK HEALTHCARE, INC. |
24 | B019ZINBS45E0 | ZIN-BS-45E | ZIN-BS-45E | Non-Infused Single-Use Z/pH Probe (External Reference), Single pH (Esophageal) | Sandhill Scientific | DIVERSATEK HEALTHCARE, INC. |
25 | B019ZANBT600 | ZAN-BT-60 | ZAN-BT-60 | Non-Infused Single-Use Z/pH Probe (Internal Reference), Triple Sensor | Sandhill Scientific | DIVERSATEK HEALTHCARE, INC. |
26 | B019ZANBS01E0 | ZAN-BS-01E | ZAN-BS-01E | Single-Use Z/pH Probe (External Reference), Single pH (Esophageal) | Sandhill Scientific | DIVERSATEK HEALTHCARE, INC. |
27 | B019ZANBS010 | ZAN-BS-01 | ZAN-BS-01 | Non-Infused Single-Use Z/pH Probe (Internal Reference), Single pH (Esophageal) | Sandhill Scientific | DIVERSATEK HEALTHCARE, INC. |
28 | B019ZANBG44E0 | ZAN-BG-44E | ZAN-BG-44E | Single-Use Z/pH Probe (External Reference), Dual pH (Gastric & Esophageal) | Sandhill Scientific | DIVERSATEK HEALTHCARE, INC. |
29 | B019ZANBG440 | ZAN-BG-44 | ZAN-BG-44 | Non-Infused Single-Use Z/pH Probe (Internal Reference), Dual pH (Gastric & Esophageal) | Sandhill Scientific | DIVERSATEK HEALTHCARE, INC. |
30 | B019ZANBD310 | ZAN-BD-31 | ZAN-BD-31 | Non-Infused Single-Use Z/pH Probe (Internal Reference), Dual pH (Esophageal) | Sandhill Scientific | DIVERSATEK HEALTHCARE, INC. |
31 | B019ZAIBS01E0 | ZAI-BS-01E | ZAI-BS-01E | Single-Use Z/pH Probe (External Reference), Single pH (Esophageal) with LES Loca Single-Use Z/pH Probe (External Reference), Single pH (Esophageal) with LES Locator, Locator Port 6cm | Sandhill Scientific | DIVERSATEK HEALTHCARE, INC. |
32 | B019ZAIBS010 | ZAI-BS-01 | ZAI-BS-01 | Infused Single-Use Z/pH Probe (Internal Reference), Single pH (Esophageal) with Infused Single-Use Z/pH Probe (Internal Reference), Single pH (Esophageal) with LES Locator, Locator Port 6cm | Sandhill Scientific | DIVERSATEK HEALTHCARE, INC. |
33 | B019ZAIBL560 | ZAI-BL-56 | ZAI-BL-56 | LPR Probe, Dual pH (Esophageal), LPR Acid, Locator Port 6cm | Sandhill Scientific | DIVERSATEK HEALTHCARE, INC. |
34 | B019ZAIBL550 | ZAI-BL-55 | ZAI-BL-55 | LPR Probe, Dual pH (Esophageal), LPR Acid, Locator Port 6cm | Sandhill Scientific | DIVERSATEK HEALTHCARE, INC. |
35 | B019ZAIBL540 | ZAI-BL-54 | ZAI-BL-54 | LPR Probe, Dual pH (Esophageal), LPR Acid, Locator Port 6cm | Sandhill Scientific | DIVERSATEK HEALTHCARE, INC. |
36 | B019ZAIBG44E0 | ZAI-BG-44E | ZAI-BG-44E | Single-Use Z/pH Probe (External Reference), Dual pH (Gastric and Esophageal), Lo Single-Use Z/pH Probe (External Reference), Dual pH (Gastric and Esophageal), Locator Port 6cm | Sandhill Scientific | DIVERSATEK HEALTHCARE, INC. |
37 | B019ZAIBG440 | ZAI-BG-44 | ZAI-BG-44 | Infused Single-Use Z/pH Probe (Internal Reference), Dual pH (Gastric and Esophag Infused Single-Use Z/pH Probe (Internal Reference), Dual pH (Gastric and Esophageal), Locator Port 6cm | Sandhill Scientific | DIVERSATEK HEALTHCARE, INC. |
38 | B019ZAIBD310 | ZAI-BD-31 | ZAI-BD-31 | Infused Single-Use Z/pH Probe (Internal Reference), Dual pH (Esophageal) with LE Infused Single-Use Z/pH Probe (Internal Reference), Dual pH (Esophageal) with LES Locator, Locator Port 6cm | Sandhill Scientific | DIVERSATEK HEALTHCARE, INC. |
39 | B019Z0790000 | Z07-2009 | Z07-2009 | ZepHr® System Kit | Sandhill Scientific | DIVERSATEK HEALTHCARE, INC. |
40 | B019Z072000BB0 | Z07-2000-B-B | Z07-2000-B-B | ZepHr® Z/pH Recorder | Sandhill Scientific | DIVERSATEK HEALTHCARE, INC. |
41 | B019Z072000BA0 | Z07-2000-B-A | Z07-2000-B-A | ZepHr® pH Recorder | Sandhill Scientific | DIVERSATEK HEALTHCARE, INC. |
42 | B019ULTSYS0 | ULTSYS | ULTSYS | InSIGHT Ultima® Manometry System | Sandhill Scientific | DIVERSATEK HEALTHCARE, INC. |
43 | B019ULTCART0 | ULTCART | ULTCART | InSIGHT Ultima® Manometry System | Sandhill Scientific | DIVERSATEK HEALTHCARE, INC. |
44 | B019ULT1SIA0 | ULT1-S-IA | ULT1-S-IA | InSIGHT Ultima® System No Workstation No Monitor Int. | Sandhill Scientific | DIVERSATEK HEALTHCARE, INC. |
45 | B019ULT1SI0 | ULT1-S-I | ULT1-S-I | InSIGHT Ultima® System No Workstation | Sandhill Scientific | DIVERSATEK HEALTHCARE, INC. |
46 | B019ULT1S0 | ULT1-S | ULT1-S | InSIGHT Ultima® Base System | Sandhill Scientific | DIVERSATEK HEALTHCARE, INC. |
47 | B019ULT1HSDI0 | ULT1-HSD-I | ULT1-HSD-I | InSIGHT Ultima® HRiM SD System Int. | Sandhill Scientific | DIVERSATEK HEALTHCARE, INC. |
48 | B019ULT1HSDD0 | ULT1-HSD-D | ULT1-HSD-D | InSIGHT Ultima® HRiM SD System | Sandhill Scientific | DIVERSATEK HEALTHCARE, INC. |
49 | B019ULT1HPI0 | ULT1-HP-I | ULT1-HP-I | InSIGHT Ultima® HRZ HRM System Int. | Sandhill Scientific | DIVERSATEK HEALTHCARE, INC. |
50 | B019ULT1HPD0 | ULT1-HP-D | ULT1-HP-D | InSIGHT Ultima® HRM System | Sandhill Scientific | DIVERSATEK HEALTHCARE, INC. |