| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00868475000273 | FGS-06-IAP.16FS | FGS-06-IAP.16FS | The Accuryn Monitoring System is intended for use in the drainage and/or collect The Accuryn Monitoring System is intended for use in the drainage and/or collection of urine, and in the monitoring of urine output and core body temperature, in degrees Fahrenheit and degrees Celsius. The Accuryn Monitoring System is also intended for use in the monitoring of intra-abdominal pressure. The measured pressures can be used as an aid in the diagnosis of intra-abdominal hypertension (IAH) and the associated clinical syndrome of abdominal compartment syndrome (ACS). | EZL | Catheter, Retention Type, Balloon | 2 | Accuryn UO/T-IAP Catheter, 16F Kit |
| 2 | 00850019755176 | FGS-06-UOT.SMCS | FGS-06-UOT.SMCS | The Accuryn Monitoring System is intended for use in the drainage and/or collect The Accuryn Monitoring System is intended for use in the drainage and/or collection of urine, and in the monitoring of urine output and core body temperature, in degrees Fahrenheit and degrees Celsius. The Accuryn Monitoring System is also intended for use in the monitoring of intra-abdominal pressure. The measured pressures can be used as an aid in the diagnosis of intra-abdominal hypertension (IAH) and the associated clinical syndrome of abdominal compartment syndrome (ACS). | EXY | Uroflowmeter | 2 | Accuryn SmartFoley Tray System Foley Adapter |
| 3 | 00850019755152 | FGS-06-CUOT.16FST | FGS-06-CUOT.16FST | The Accuryn Monitoring System is intended for use in the drainage and/or collect The Accuryn Monitoring System is intended for use in the drainage and/or collection of urine, and in the monitoring of urine output and core body temperature, in degrees Fahrenheit and degrees Celsius. The Accuryn Monitoring System is also intended for use in the monitoring of intra-abdominal pressure. The measured pressures can be used as an aid in the diagnosis of intra-abdominal hypertension (IAH) and the associated clinical syndrome of abdominal compartment syndrome (ACS). | EZL | Catheter, Retention Type, Balloon | 2 | Accuryn SmartFoley Coude UO Temp Tray System 16Fr |
| 4 | 00850019755008 | FGN-06-100779 | FGN-06-100779 | The Reusable Accuryn Temperature Cable is an accessory that connects to a temper The Reusable Accuryn Temperature Cable is an accessory that connects to a temperature-sensing Foley catheter's thermistor plug and temperature port on the Accuryn Monitor for continuous temperature measurement. | PHU,EXY | Intra-Abdominal Pressure Monitoring Device,Uroflowmeter | 2 | Accuryn Temperature Cable |
| 5 | 00850019755220 | FGN-06-100195 | FGN-06-100195 | The Accuryn Monitor Floor Stand is used to hold the Accuryn Monitor on the floor The Accuryn Monitor Floor Stand is used to hold the Accuryn Monitor on the floor near the patient’s bed during stationary use. The Accuryn Monitor Floor Stand is an accessory to the Accuryn Monitoring System. | PHU,EXY | Intra-Abdominal Pressure Monitoring Device,Uroflowmeter | 2 | Accuryn Monitor Floor Stand |
| 6 | 00868475000235 | FGN-06-2687 | FGN-06-2687 | The Accuryn Monitoring System is intended for use in the drainage and/or collect The Accuryn Monitoring System is intended for use in the drainage and/or collection of urine, and in the monitoring of urine output and core body temperature, in degrees Fahrenheit and degrees Celsius. The Accuryn Monitoring System is also intended for use in the monitoring of intra-abdominal pressure. The measured pressures can be used as an aid in the diagnosis of intra-abdominal hypertension (IAH) and the associated clinical syndrome of abdominal compartment syndrome (ACS). | PHU,EXY | Intra-Abdominal Pressure Monitoring Device,Uroflowmeter | 2 | Accuryn Monitor |
| 7 | 00850019755244 | FGN-06-102112 | FGN-06-102112 | The Accuryn Monitor High Mount is used to hold Accuryn Monitor near the patient’ The Accuryn Monitor High Mount is used to hold Accuryn Monitor near the patient’s bed during stationary use or transport. The Monitor High Mount can also be placed on top of the Floor Stand to raise the drainage bag up to drain the bag more easily. The Accuryn Monitor High Mount is an accessory to the Accuryn Monitoring System. | PHU,EXY | Intra-Abdominal Pressure Monitoring Device,Uroflowmeter | 2 | Accuryn Monitor High Mount |
| 8 | 00850019755121 | FGS-06-IAP.16FST | FGS-06-IAP.16FST | The Accuryn Monitoring System is intended for use in the drainage and/or collect The Accuryn Monitoring System is intended for use in the drainage and/or collection of urine, and in the monitoring of urine output and core body temperature, in degrees Fahrenheit and degrees Celsius. The Accuryn Monitoring System is also intended for use in the monitoring of intra-abdominal pressure. The measured pressures can be used as an aid in the diagnosis of intra-abdominal hypertension (IAH) and the associated clinical syndrome of abdominal compartment syndrome (ACS). | EZL | Catheter, Retention Type, Balloon | 2 | Accuryn SmartFoley IAP UO Temp Tray System 16Fr |
| 9 | 00868475000280 | FGS-06-UOT.SMCS | FGS-06-UOT.SMCS | The Accuryn Monitoring System is intended for use in the drainage and/or collect The Accuryn Monitoring System is intended for use in the drainage and/or collection of urine, and in the monitoring of urine output and core body temperature, in degrees Fahrenheit and degrees Celsius. The Accuryn Monitoring System is also intended for use in the monitoring of intra-abdominal pressure. The measured pressures can be used as an aid in the diagnosis of intra-abdominal hypertension (IAH) and the associated clinical syndrome of abdominal compartment syndrome (ACS). | EXY | Uroflowmeter | 2 | Accuryn UO/T, Smart Cath Kit |
| 10 | 00850019755145 | FGS-06-UOT.16FST | FGS-06-UOT.16FST | The Accuryn Monitoring System is intended for use in the drainage and/or collect The Accuryn Monitoring System is intended for use in the drainage and/or collection of urine, and in the monitoring of urine output and core body temperature, in degrees Fahrenheit and degrees Celsius. The Accuryn Monitoring System is also intended for use in the monitoring of intra-abdominal pressure. The measured pressures can be used as an aid in the diagnosis of intra-abdominal hypertension (IAH) and the associated clinical syndrome of abdominal compartment syndrome (ACS). | EZL | Catheter, Retention Type, Balloon | 2 | Accuryn SmartFoley UO Temp Tray System 16Fr |
| 11 | 00850019755237 | FGN-06-100202 | FGN-06-100202 | The Accuryn Monitor Mount with Clamp consists of a handle, monitor attachment pi The Accuryn Monitor Mount with Clamp consists of a handle, monitor attachment piece, and clamp with knob. The monitor may be attached to an IV Pole with the pole-clamp and knob. The Accuryn Monitor Mount with Clamp is an accessory to the Accuryn Monitoring System. | PHU,EXY | Intra-Abdominal Pressure Monitoring Device,Uroflowmeter | 2 | Accuryn Monitor Mount with Clamp |
| 12 | 00850019755206 | FGN-06-102306 | FGN-06-102306 | A reusable short cable adapter that adapts Foleys with 3.5mm round connectors to A reusable short cable adapter that adapts Foleys with 3.5mm round connectors to the Reusable Accuryn Temperature Cable. The Accuryn Temperature Cable Adapter is an accessory of the Accuryn Monitoring System. | PHU,EXY | Intra-Abdominal Pressure Monitoring Device,Uroflowmeter | 2 | Accuryn Temperature Cable Adapter |
| 13 | 00868475000297 | FGS-06-UOT.16FS | FGS-06-UOT.16FS | The Accuryn Monitoring System is intended for use in the drainage and/or collect The Accuryn Monitoring System is intended for use in the drainage and/or collection of urine, and in the monitoring of urine output and core body temperature, in degrees Fahrenheit and degrees Celsius. The Accuryn Monitoring System is also intended for use in the monitoring of intra-abdominal pressure. The measured pressures can be used as an aid in the diagnosis of intra-abdominal hypertension (IAH) and the associated clinical syndrome of abdominal compartment syndrome (ACS). | EZL | Catheter, Retention Type, Balloon | 2 | Accuryn UO/T Catheter, 16F Kit |
| 14 | 00850019755251 | FGN-06-102111 | FGN-06-102111 | The Accuryn Monitor High Mount & Floor Stand is a set consisting of one Accuryn The Accuryn Monitor High Mount & Floor Stand is a set consisting of one Accuryn Monitor High Mount and one Accuryn Monitor Floor Stand. The Accuryn Monitor High Mount & Floor Stand is an accessory to the Accuryn Monitoring System. | PHU,EXY | Intra-Abdominal Pressure Monitoring Device,Uroflowmeter | 2 | Accuryn Monitor High Mount & Floor Stand |
| 15 | 00850019755213 | FGN-06-102427 | FGN-06-102427 | The Accuryn Monitor Short Floor Stand is used to hold the Accuryn Monitor on the The Accuryn Monitor Short Floor Stand is used to hold the Accuryn Monitor on the floor near the patient’s bed during stationary use. The Accuryn Monitor Short Floor Stand is an accessory of the Accuryn Monitoring System. | PHU,EXY | Intra-Abdominal Pressure Monitoring Device,Uroflowmeter | 2 | Accuryn Monitor Short Floor Stand |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 10704411009641 | 1 | Hydrophilic Latex Foley Catheters, 14FR, 30cc. | AMSure ® Hydrophilic Latex Foley Catheters | AMSINO INTERNATIONAL, INC. | |
| 2 | 10704411009085 | 1 | Hydrophilic Latex Foley Catheters, 28FR, 30cc. | AMSure ® Hydrophilic Latex Foley Catheters | AMSINO INTERNATIONAL, INC. | |
| 3 | 10704411009078 | 1 | Hydrophilic Latex Foley Catheters, 26FR, 30cc. | AMSure ® Hydrophilic Latex Foley Catheters | AMSINO INTERNATIONAL, INC. | |
| 4 | 10704411009061 | 1 | Hydrophilic Latex Foley Catheters, 24FR, 30cc. | AMSure ® Hydrophilic Latex Foley Catheters | AMSINO INTERNATIONAL, INC. | |
| 5 | 10704411009054 | 1 | Hydrophilic Latex Foley Catheters, 22FR, 30cc. | AMSure ® Hydrophilic Latex Foley Catheters | AMSINO INTERNATIONAL, INC. | |
| 6 | 10704411009047 | 1 | Hydrophilic Latex Foley Catheters, 20FR, 30cc. | AMSure ® Hydrophilic Latex Foley Catheters | AMSINO INTERNATIONAL, INC. | |
| 7 | 10704411009030 | 1 | Hydrophilic Latex Foley Catheters, 18FR, 30cc. | AMSure ® Hydrophilic Latex Foley Catheters | AMSINO INTERNATIONAL, INC. | |
| 8 | 10704411009023 | 1 | Hydrophilic Latex Foley Catheters, 16FR, 30cc. | AMSure ® Hydrophilic Latex Foley Catheters | AMSINO INTERNATIONAL, INC. | |
| 9 | 10704411009016 | 1 | Hydrophilic Latex Foley Catheters, 28FR, 5cc. | AMSure ® Hydrophilic Latex Foley Catheters | AMSINO INTERNATIONAL, INC. | |
| 10 | 10704411009009 | 1 | Hydrophilic Latex Foley Catheters, 26FR, 5cc. | AMSure ® Hydrophilic Latex Foley Catheters | AMSINO INTERNATIONAL, INC. | |
| 11 | 10704411008996 | 1 | Hydrophilic Latex Foley Catheters, 24FR, 5cc. | AMSure ® Hydrophilic Latex Foley Catheters | AMSINO INTERNATIONAL, INC. | |
| 12 | 10704411008989 | 1 | Hydrophilic Latex Foley Catheters, 22FR, 5cc. | AMSure ® Hydrophilic Latex Foley Catheters | AMSINO INTERNATIONAL, INC. | |
| 13 | 10704411008972 | 1 | Hydrophilic Latex Foley Catheters, 20FR, 5cc. | AMSure ® Hydrophilic Latex Foley Catheters | AMSINO INTERNATIONAL, INC. | |
| 14 | 10704411008965 | 1 | Hydrophilic Latex Foley Catheters, 18FR, 5cc. | AMSure ® Hydrophilic Latex Foley Catheters | AMSINO INTERNATIONAL, INC. | |
| 15 | 10704411008958 | 1 | Hydrophilic Latex Foley Catheters, 16FR, 5cc. | AMSure ® Hydrophilic Latex Foley Catheters | AMSINO INTERNATIONAL, INC. | |
| 16 | 10704411008941 | 1 | Hydrophilic Latex Foley Catheters, 14FR, 5cc. | AMSure ® Hydrophilic Latex Foley Catheters | AMSINO INTERNATIONAL, INC. | |
| 17 | 10704411008934 | 1 | Hydrophilic Latex Foley Catheters, 12FR, 5cc. | AMSure ® Hydrophilic Latex Foley Catheters | AMSINO INTERNATIONAL, INC. | |
| 18 | 10704411008927 | 1 | Hydrophilic Latex Foley Catheters, 10FR., 3cc. | AMSure ® Hydrophilic Latex Foley Catheters | AMSINO INTERNATIONAL, INC. | |
| 19 | 10704411008910 | 1 | AS40008H | Hydrophilic Latex Foley Catheters, 8FR., 3cc. | AMSure ® Hydrophilic Latex Foley Catheters | AMSINO INTERNATIONAL, INC. |
| 20 | 10704411002161 | 1 | AS43026S | AMSure® 100% Silicone Foley CatheterRadiopaque | AMSure® 100% Silicone Foley Catheter | AMSINO INTERNATIONAL, INC. |
| 21 | 10704411002154 | 1 | AS43024S | AMSure® 100% Silicone Foley CatheterRadiopaque | AMSure® 100% Silicone Foley Catheter | AMSINO INTERNATIONAL, INC. |
| 22 | 10704411002147 | 1 | AS43022S | AMSure® 100% Silicone Foley CatheterRadiopaque | AMSure® 100% Silicone Foley Catheter | AMSINO INTERNATIONAL, INC. |
| 23 | 10704411002130 | 1 | AS43020S | AMSure® 100% Silicone Foley CatheterRadiopaque | AMSure® 100% Silicone Foley Catheter | AMSINO INTERNATIONAL, INC. |
| 24 | 10704411002123 | 1 | AS43018S | AMSure® 100% Silicone Foley CatheterRadiopaque | AMSure® 100% Silicone Foley Catheter | AMSINO INTERNATIONAL, INC. |
| 25 | 10704411002116 | 1 | AS43016S | AMSure® 100% Silicone Foley CatheterRadiopaque | AMSure® 100% Silicone Foley Catheter | AMSINO INTERNATIONAL, INC. |
| 26 | 10704411002109 | 1 | AS42030S | AMSure® 100% Silicone Foley CatheterRadiopaque | AMSure® 100% Silicone Foley Catheter | AMSINO INTERNATIONAL, INC. |
| 27 | 10704411002093 | 1 | AS42028S | AMSure® 100% Silicone Foley CatheterRadiopaque | AMSure® 100% Silicone Foley Catheter | AMSINO INTERNATIONAL, INC. |
| 28 | 10704411002086 | 1 | AS42026S | AMSure® 100% Silicone Foley CatheterRadiopaque | AMSure® 100% Silicone Foley Catheter | AMSINO INTERNATIONAL, INC. |
| 29 | 10704411002079 | 1 | AS42024S | AMSure® 100% Silicone Foley CatheterRadiopaque | AMSure® 100% Silicone Foley Catheter | AMSINO INTERNATIONAL, INC. |
| 30 | 10704411002062 | 1 | AS42022S | AMSure® 100% Silicone Foley CatheterRadiopaque | AMSure® 100% Silicone Foley Catheter | AMSINO INTERNATIONAL, INC. |
| 31 | 10704411002055 | 1 | AS42020S | AMSure® 100% Silicone Foley CatheterRadiopaque | AMSure® 100% Silicone Foley Catheter | AMSINO INTERNATIONAL, INC. |
| 32 | 10704411002048 | 1 | AS42018S | AMSure® 100% Silicone Foley CatheterRadiopaque | AMSure® 100% Silicone Foley Catheter | AMSINO INTERNATIONAL, INC. |
| 33 | 10704411002031 | 1 | AS42016S | AMSure® 100% Silicone Foley CatheterRadiopaque | AMSure® 100% Silicone Foley Catheter | AMSINO INTERNATIONAL, INC. |
| 34 | 10704411002024 | 1 | AS42014S | AMSure® 100% Silicone Foley CatheterRadiopaque | AMSure® 100% Silicone Foley Catheter | AMSINO INTERNATIONAL, INC. |
| 35 | 10704411002017 | 1 | AS42012S | AMSure® 100% Silicone Foley CatheterRadiopaque | AMSure® 100% Silicone Foley Catheter | AMSINO INTERNATIONAL, INC. |
| 36 | 10704411002000 | 1 | AS41030S | AMSure® 100% Silicone Foley CatheterRadiopaque | AMSure® 100% Silicone Foley Catheter | AMSINO INTERNATIONAL, INC. |
| 37 | 10704411001997 | 1 | AS41028S | AMSure® 100% Silicone Foley CatheterRadiopaque | AMSure® 100% Silicone Foley Catheter | AMSINO INTERNATIONAL, INC. |
| 38 | 10704411001980 | 1 | AS41026S | AMSure® 100% Silicone Foley CatheterRadiopaque | AMSure® 100% Silicone Foley Catheter | AMSINO INTERNATIONAL, INC. |
| 39 | 10704411001973 | 1 | AS41024S | AMSure® 100% Silicone Foley CatheterRadiopaque | AMSure® 100% Silicone Foley Catheter | AMSINO INTERNATIONAL, INC. |
| 40 | 10704411001966 | 1 | AS41022S | AMSure® 100% Silicone Foley CatheterRadiopaque | AMSure® 100% Silicone Foley Catheter | AMSINO INTERNATIONAL, INC. |
| 41 | 10704411001959 | 1 | AS41020S | AMSure® 100% Silicone Foley CatheterRadiopaque | AMSure® 100% Silicone Foley Catheter | AMSINO INTERNATIONAL, INC. |
| 42 | 10704411001942 | 1 | AS41018S | AMSure® 100% Silicone Foley CatheterRadiopaque | AMSure® 100% Silicone Foley Catheter | AMSINO INTERNATIONAL, INC. |
| 43 | 10704411001935 | 1 | AS41016S | AMSure® 100% Silicone Foley CatheterRadiopaque | AMSure® 100% Silicone Foley Catheter | AMSINO INTERNATIONAL, INC. |
| 44 | 10704411001928 | 1 | AS41014S | AMSure® 100% Silicone Foley CatheterRadiopaque | AMSure® 100% Silicone Foley Catheter | AMSINO INTERNATIONAL, INC. |
| 45 | 10704411001911 | 1 | AS41012S | AMSure® 100% Silicone Foley CatheterRadiopaque | AMSure® 100% Silicone Foley Catheter | AMSINO INTERNATIONAL, INC. |
| 46 | 10704411001904 | 1 | AS40010S | AMSure® 100% Silicone Foley CatheterRadiopaque | AMSure® 100% Silicone Foley Catheter | AMSINO INTERNATIONAL, INC. |
| 47 | 10704411001898 | 1 | AS40008S | AMSure® 100% Silicone Foley CatheterRadiopaque | AMSure® 100% Silicone Foley Catheter | AMSINO INTERNATIONAL, INC. |
| 48 | 10704411001775 | 1 | AS43026 | AMSure® Silicone Coated Latex Foley Catheter | AMSure® Silicone Coated Latex Foley Catheter | AMSINO INTERNATIONAL, INC. |
| 49 | 10704411001768 | 1 | AS43024 | AMSure® Silicone Coated Latex Foley Catheter | AMSure® Silicone Coated Latex Foley Catheter | AMSINO INTERNATIONAL, INC. |
| 50 | 10704411001751 | 1 | AS43022 | AMSure® Silicone Coated Latex Foley Catheter | AMSure® Silicone Coated Latex Foley Catheter | AMSINO INTERNATIONAL, INC. |