ZYNO MEDICAL LLC

Address:177 Pine St,Natick,MA,01760,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Set, Administration, Intravascular (FPA) (10)

Premarket Exempt

Clear

Zyno - 00814371020563 Catalog Number : BX-70071-P

Device Description : BX Administration Primary Set: 105" 1 NF Y-Site Above Pump, Back Check-Valve, An 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.

Device Class : 2

Duns Number: 030899271

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

Zyno - 00814371020570 Catalog Number : BX-70072

Device Description : BX Administration Primary Set: 105" 2 NF Y-Site, 1 Above, 1 Below Pump, Back Che 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.

Device Class : 2

Duns Number: 030899271

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

Zyno - 00814371020587 Catalog Number : BX-70072-F

Device Description : BX Administration Primary Set: 105" 2 NF Y-Site, 1 Above, 1 Below Pump, .22 Filt 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.

Device Class : 2

Duns Number: 030899271

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

Zyno - 00814371020600 Catalog Number : AA-80075

Device Description : Universal Secondary IV Administration Set: Use with all Z-800 Series Pumps, 40", 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.

Device Class : 2

Duns Number: 030899271

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

Zyno - 10814371020058 Catalog Number : A2-80070

Device Description : A2 Primary Administration Set: 105" Straight Line Set, Roller Clamp. A2 Primary 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.

Device Class :

Duns Number: 030899271

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 50

Zyno - 10814371020065 Catalog Number : A2-80071-D

Device Description : A2 Administration Primary Set: 105" 1 NF Y-Site Below Pump, Roller Clamp. A2 Pri 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.

Device Class :

Duns Number: 030899271

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 50

Zyno - 10814371020072 Catalog Number : A2-80071-DF

Device Description : A2 Administration Primary Set: 105" 1 NF Y-Site Below Pump, In-line 0.22 Filter, 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.

Device Class :

Duns Number: 030899271

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 50

Zyno - 10814371020089 Catalog Number : A2-80071-DF120

Device Description : A2 Administration Primary Set: 105" 1 NF Y-Site Below Pump, In-line 1.2 Filter, 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.

Device Class :

Duns Number: 030899271

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 50

Zyno - 10814371020096 Catalog Number : A2-80071-P

Device Description : A2 Administration Primary Set: 105" 1 NF Y Site above Pump, Back Check-Valve. A2 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.

Device Class :

Duns Number: 030899271

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 50

Zyno - 10814371020102 Catalog Number : A2-80071-PF

Device Description : A2 Administration Primary Set: 105" 1 NF Y-Site Above Pump, In-line 0.22 Filter, 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.

Device Class :

Duns Number: 030899271

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 50

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