zynomed.comHalo II Ambulatory Infusion System (also With Trade Names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System)
ZYNO MEDICAL LLC
Zyno Medical LLC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3006575795 | 3006575795 | Zyno Medical LLC. | 1 | N | 2026-01-01 | 177 Pine St Natick MA US 01760 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00814371020006 | Z-800 - Large volume infusion pump | 866-395-1988 | support@zynomed.com |
| 00814371020013 | Z-800F - Large volume infusion pump | 866-395-1988 | support@zynomed.com |
| 00814371020020 | Z-800W - Large volume infusion pump | 866-395-1988 | support@zynomed.com |
| 00814371020037 | Z-800WF - Large volume infusion pump | 866-395-1988 | support@zynomed.com |
| 00814371020044 | Nimbus - Ambulatory Infusion Pump | 866-395-1988 | support@zynomed.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 72606 | 1908105056 | K882302 | IVAC(R) UNVENTED VOL. INFUSION SET MODEL 52080 | FPA | 1988-07-12 |
| 72606 | 1772840462 | K132841 | ZYNO MEDICAL ADMINISTRATION SET | FPA | 2014-01-23 |
| 72606 | 1396782517 | K130690 | Z-800 INFUSION SYSTEM | FRN | 2013-06-12 |
| 72606 | 1296068007 | K120685 | ZYNO MEDICAL ADMINISTRATION SET | FPA | 2012-09-07 |
| 72606 | 1369154792 | K100705 | ZYNO Z-800 INFUSION SYSTEM MODEL Z-800 | FRN | 2010-07-08 |
Product Codes Associated With Registrations#
PMN#
HALO AMBULATORY INFUSION SYSTEM
ZYNO MEDICAL LLC.
ZYNO MEDICAL ADMINISTRATION SET
ZYNO MEDICAL LLC
Z-800 INFUSION SYSTEM
ZYNO MEDICAL LLC
ZYNO MEDICAL ADMINISTRATION SET
ZYNO MEDICAL LLC
ZYNO Z-800 INFUSION SYSTEM MODEL Z-800
ZYNO MEDICAL LLC
Z-800 VOLUMETRIC INFUSION PUMP
ZYNO MEDICAL LLC
GUDID#
Z-800F - Large volume infusion pump
2015-10-13
Z-800W - Large volume infusion pump
2015-10-13
Z-800WF - Large volume infusion pump
2015-10-13
Nimbus - Ambulatory Infusion Pump
2015-10-13
Z-800 - Large volume infusion pump
2015-10-13
Zyno - "A2 Primary Administration Set: 105"" Straight Line Set, Roller Clamp. A2 Primary Administration Sets are single-use IV administration sets for use with Z-800 Zyno Medical Infusion pump. All A2 Primary sets fluid paths are sterile, non-Pyrogenic, are not made with natural rubber latex, and are not made with DEHP."
2016-09-23
Zyno - "A2 Administration Primary Set: 105"" 1 NF Y-Site Below Pump, Roller Clamp. A2 Primary Administration Sets are single-use IV administration sets for use with Z-800 Zyno Medical Infusion pump. All A2 Primary sets fluid paths are sterile, non-Pyrogenic, are not made with natural rubber latex, and are not made with DEHP."
2016-09-23
Zyno - "A2 Administration Primary Set: 105"" 1 NF Y-Site Below Pump, In-line 0.22 Filter, Pinch Clamp. A2 Primary Administration Sets are single-use IV administration sets for use with Z-800 Zyno Medical Infusion pump. All A2 Primary sets fluid paths are sterile, non-Pyrogenic, are not made with natural rubber latex, and are not made with DEHP."
2016-09-23
Zyno - "A2 Administration Primary Set: 105"" 1 NF Y-Site Below Pump, In-line 1.2 Filter, Pinch Clamp. A2 Primary Administration Sets are single-use IV administration sets for use with Z-800 Zyno Medical Infusion pump. All A2 Primary sets fluid paths are sterile, non-Pyrogenic, are not made with natural rubber latex, and are not made with DEHP."
2016-09-23
Zyno - "A2 Administration Primary Set: 105"" 1 NF Y Site above Pump, Back Check-Valve. A2 Primary Administration Sets are single-use IV administration sets for use with Z-800 Zyno Medical Infusion pump. All A2 Primary sets fluid paths are sterile, non-Pyrogenic, are not made with natural rubber latex, and are not made with DEHP."
2016-09-23
Zyno - "A2 Administration Primary Set: 105"" 1 NF Y-Site Above Pump, In-line 0.22 Filter, Back Check-Valve. A2 Primary Administration Sets are single-use IV administration sets for use with Z-800 Zyno Medical Infusion pump. All A2 Primary sets fluid paths are sterile, non-Pyrogenic, are not made with natural rubber latex, and are not made with DEHP."
2016-09-23
Zyno - "A2 Administration Primary Set: 105"" 2 NF Y-Site, 1 Above, 1 Below Pump, Back Check-Valve. A2 Primary Administration Sets are single-use IV administration sets for use with Z-800 Zyno Medical Infusion pump. All A2 Primary sets fluid paths are sterile, non-Pyrogenic, are not made with natural rubber latex, and are not made with DEHP."
2016-09-23
Zyno - "A2 Administration Primary Set: 105"" 2 NF Y-Site, 1 Below, 1 Above Pump, In-Line .22 Filter, Back Check-Valve. A2 Primary Administration Sets are single-use IV administration sets for use with Z-800 Zyno Medical Infusion pump. All A2 Primary sets fluid paths are sterile, non-Pyrogenic, are not made with natural rubber latex, and are not made with DEHP."
2016-09-23
Zyno - "Universal Secondary IV Administration Set: Use with all Z-800 Series Pumps, 40"", Bag Hanger, Roller Clamp. Secondary Administration Sets are single-use IV administration sets for use with Z-800, Z-800F, Z-800W and Z-800WF Zyno Medical Infusion pumps. All A2 Secondary sets fluid paths are sterile, non-Pyrogenic, are not made with natural rubber latex, and are not made with DEHP."
2016-09-23
Zyno - "B2 Primary Administration Set: 105"" Straight Line Set, Anti-Free Flow Clamp. B2 Primary Administration Sets are single-use IV administration sets for use with Z-800F, Z-800W and Z-800WF Zyno Medical Infusion pumps. All B2 Primary sets fluid paths are sterile, non-Pyrogenic, are not made with natural rubber latex, and are not made with DEHP."
2016-09-23
Zyno - "B2 Administration Primary Set: 105"" 1 NF Y-Site Below Pump, Anti-Free Flow Clamp. B2 Primary Administration Sets are single-use IV administration sets for use with Z-800F, Z-800W and Z-800WF Zyno Medical Infusion pumps. All B2 Primary sets fluid paths are sterile, non-Pyrogenic, are not made with natural rubber latex, and are not made with DEHP."
2016-09-23
Zyno - "B2 Administration Primary Set: 105"" 1 NF Y-Site Below Pump, .22 Filter, Back Check-Valve, Anti-Free Flow Clamp. B2 Primary Administration Sets are single-use IV administration sets for use with Z-800F, Z-800W and Z-800WF Zyno Medical Infusion pumps. All B2 Primary sets fluid paths are sterile, non-Pyrogenic, are not made with natural rubber latex, and are not made with DEHP."
2016-09-23
Zyno - "B2 Administration Primary Set: 105"" 1 NF Y Site Below Pump, 1.2 Filter, Anti-Free Flow Clamp. B2 Primary Administration Sets are single-use IV administration sets for use with Z-800F, Z-800W and Z-800WF Zyno Medical Infusion pumps. All B2 Primary sets fluid paths are sterile, non-Pyrogenic, are not made with natural rubber latex, and are not made with DEHP."
2016-09-23
Zyno - "B2 Administration Primary Set: 105"" 1 NF Y-Site Above Pump, Back Check-Valve, Anti-Free Flow Clamp. B2 Primary Administration Sets are single-use IV administration sets for use with Z-800F, Z-800W and Z-800WF Zyno Medical Infusion pumps. All B2 Primary sets fluid paths are sterile, non-Pyrogenic, are not made with natural rubber latex, and are not made with DEHP."
2016-09-23
Zyno - "B2 Administration Primary Set: 105"" 2 NF Y-Site, 1 Above, 1 Below Pump, Back Check-Valve, Anti-Free Flow Clamp. B2 Primary Administration Sets are single-use IV administration sets for use with Z-800F, Z-800W and Z-800WF Zyno Medical Infusion pumps. All B2 Primary sets fluid paths are sterile, non-Pyrogenic, are not made with natural rubber latex, and are not made with DEHP."
2016-09-23
Zyno - "B2 Administration Primary Set: 105"" 2 NF Y-Site, 1 Above, 1 Below Pump, .22 Filter, Back Check-Valve, Anti-Free Flow Clamp. B2 Primary Administration Sets are single-use IV administration sets for use with Z-800F, Z-800W and Z-800WF Zyno Medical Infusion pumps. All B2 Primary sets fluid paths are sterile, non-Pyrogenic, are not made with natural rubber latex, and are not made with DEHP."
2016-09-23
Zyno - "Extension Set: 10"" In-Line .22 Micron Filter, Slide Clamp. Extension Sets are single-use IV administration sets for use with Z-800, Z-800F, Z-800W and Z-800WF Zyno Medical Infusion pumps. All extension sets fluid paths are sterile, non-Pyrogenic are not made with natural rubber latex, and are not made with DEHP."
2016-09-23
Zyno - "Extension Set: 14"" In-Line 1.2 Micron Filter, Slide Clamp. Extension Sets are single-use IV administration setsfor use with Z-800, Z-800F, Z-800W and Z-800WF Zyno Medical Infusion pumps. All extension sets fluid paths are sterile, non-Pyrogenic, are not made with natural rubber latex, and are not made with DEHP."
2016-09-23
Zyno - "AX Primary Administration Set: 105"" Straight Line Set, Roller Clamp. AX Primary Administration Sets are single-use IV administration sets for use with Z-800 Zyno Medical Infusion pump. All AX Primary sets fluid paths are sterile, non-Pyrogenic, are not made with natural rubber latex, and are not made with DEHP."
2016-09-23
Zyno - "AX Administration Primary Set: 105"" 1 NF Y-Site Below Pump, Roller Clamp. AX Primary Administration Sets are single-use IV administration sets for use with Z-800 Zyno Medical Infusion pump. All AX Primary sets fluid paths are sterile, non-Pyrogenic, are not made with natural rubber latex, and are not made with DEHP."
2016-09-23
Zyno - "AX Administration Primary Set: 105"" 1 NF Y-Site Below Pump, In-line 0.22 Filter, Pinch Clamp. AX Primary Administration Sets are single-use IV administration sets for use with Z-800 Zyno Medical Infusion pump. All AX Primary sets fluid paths are sterile, non-Pyrogenic, are not made with natural rubber latex, and are not made with DEHP."
2016-09-23
Zyno - "AX Administration Primary Set: 105"" 1 NF Y-Site Below Pump, In-line 1.2 Filter, Pinch Clamp. AX Primary Administration Sets are single-use IV administration sets for use with Z-800 Zyno Medical Infusion pump. All AX Primary sets fluid paths are sterile, non-Pyrogenic, are not made with natural rubber latex, and are not made with DEHP."
2016-09-23
Zyno - "AX Administration Primary Set: 105"" 1 NF Y Site above Pump, Back Check-Valve. AX Primary Administration Sets are single-use IV administration sets for use with Z-800 Zyno Medical Infusion pump. All AX Primary sets fluid paths are sterile, non-Pyrogenic, are not made with natural rubber latex, and are not made with DEHP."
2016-09-23
Zyno - "AX Administration Primary Set: 105"" 1 NF Y-Site Above Pump, In-line 0.22 Filter, Back Check-Valve. AX Primary Administration Sets are single-use IV administration sets for use with Z-800 Zyno Medical Infusion pump. All AX Primary sets fluid paths are sterile, non-Pyrogenic, are not made with natural rubber latex, and are not made with DEHP."
2016-09-23
Zyno - "AX Administration Primary Set: 105"" 2 NF Y-Site, 1 Above, 1 Below Pump, Back Check-Valve. AX Primary Administration Sets are single-use IV administration sets for use with Z-800 Zyno Medical Infusion pump. All AX Primary sets fluid paths are sterile, non-Pyrogenic, are not made with natural rubber latex, and are not made with DEHP."
2016-09-23
Zyno - "AX Administration Primary Set: 105"" 2 NF Y-Site, 1 Below, 1 Above Pump, In-Line .22 Filter, Back Check-Valve. AX Primary Administration Sets are single-use IV administration sets for use with Z-800 Zyno Medical Infusion pump. All AX Primary sets fluid paths are sterile, non-Pyrogenic, are not made with natural rubber latex, and are not made with DEHP."
2016-09-23
Zyno - "Universal Secondary IV Administration Set: Use with all Z-800 Series Pumps, 40"", Bag Hanger, Roller Clamp. Secondary Administration Sets are single-use IV administration sets for use with Z-800, Z-800F, Z-800W and Z-800WF Zyno Medical Infusion pumps. All AX Secondary sets fluid paths are sterile, non-Pyrogenic, are not made with natural rubber latex, and are not made with DEHP."
2016-09-23
Zyno - "BX Primary Administration Set: 105"" Straight Line Set, Anti-Free Flow Clamp. BX Primary Administration Sets are single-use IV administration sets for use with Z-800F, Z-800W and Z-800WF Zyno Medical Infusion pumps. All BX Primary sets fluid paths are sterile, non-Pyrogenic, are not made with natural rubber latex, and are not made with DEHP."
2016-09-23
Zyno - "BX Administration Primary Set: 105"" 1 NF Y-Site Below Pump, Anti-Free Flow Clamp. BX Primary Administration Sets are single-use IV administration sets for use with Z-800F, Z-800W and Z-800WF Zyno Medical Infusion pumps. All BX Primary sets fluid paths are sterile, non-Pyrogenic, are not made with natural rubber latex, and are not made with DEHP."
2016-09-23
Zyno - "BX Administration Primary Set: 105"" 1 NF Y-Site Below Pump, .22 Filter, Back Check-Valve, Anti-Free Flow Clamp. BX Primary Administration Sets are single-use IV administration sets for use with Z-800F, Z-800W and Z-800WF Zyno Medical Infusion pumps. All BX Primary sets fluid paths are sterile, non-Pyrogenic, are not made with natural rubber latex, and are not made with DEHP."
2016-09-23
Zyno - "BX Administration Primary Set: 105"" 1 NF Y Site Below Pump, 1.2 Filter, Anti-Free Flow Clamp. BX Primary Administration Sets are single-use IV administration sets for use with Z-800F, Z-800W and Z-800WF Zyno Medical Infusion pumps. All BX Primary sets fluid paths are sterile, non-Pyrogenic, are not made with natural rubber latex, and are not made with DEHP."
2016-09-23
Zyno - "BX Administration Primary Set: 105"" 1 NF Y-Site Above Pump, Back Check-Valve, Anti-Free Flow Clamp. BX Primary Administration Sets are single-use IV administration sets for use with Z-800F, Z-800W and Z-800WF Zyno Medical Infusion pumps. All BX Primary sets fluid paths are sterile, non-Pyrogenic, are not made with natural rubber latex, and are not made with DEHP."
2016-09-23
Zyno - "BX Administration Primary Set: 105"" 2 NF Y-Site, 1 Above, 1 Below Pump, Back Check-Valve, Anti-Free Flow Clamp. BX Primary Administration Sets are single-use IV administration sets for use with Z-800F, Z-800W and Z-800WF Zyno Medical Infusion pumps. All BX Primary sets fluid paths are sterile, non-Pyrogenic, are not made with natural rubber latex, and are not made with DEHP."
2016-09-23
Zyno - "BX Administration Primary Set: 105"" 2 NF Y-Site, 1 Above, 1 Below Pump, .22 Filter, Back Check-Valve, Anti-Free Flow Clamp. BX Primary Administration Sets are single-use IV administration sets for use with Z-800F, Z-800W and Z-800WF Zyno Medical Infusion pumps. All BX Primary sets fluid paths are sterile, non-Pyrogenic, are not made with natural rubber latex, and are not made with DEHP."
2016-09-23
Zyno - "Universal Secondary IV Administration Set: Use with all Z-800 Series Pumps, 40"", Bag Hanger, Roller Clamp. Secondary Administration Sets are single-use IV administration sets for use with Z-800, Z-800F, Z-800W and Z-800WF Zyno Medical Infusion pumps. All AA Secondary sets fluid paths are sterile, non-Pyrogenic, are not made with natural rubber latex, and are not made with DEHP."
2016-09-23