ZYNO MEDICAL LLC

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

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Filters

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

Pump, Infusion (FRN) (5) Set, Administration, Intravascular (FPA) (5) Pump, Infusion, Pca (MEA) (1)

Premarket Exempt

Clear

Z-800 - 00814371020006 Catalog Number : Z-800

Device Description : Large volume infusion pump

Device Class :

Duns Number: 030899271

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

Z-800F - 00814371020013 Catalog Number : Z-800F

Device Description : Large volume infusion pump

Device Class :

Duns Number: 030899271

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

Z-800W - 00814371020020 Catalog Number : Z-800W

Device Description : Large volume infusion pump

Device Class :

Duns Number: 030899271

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

Z-800WF - 00814371020037 Catalog Number : Z-800WF

Device Description : Large volume infusion pump

Device Class :

Duns Number: 030899271

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

Nimbus - 00814371020044 Catalog Number : Nimbus

Device Description : Ambulatory Infusion Pump

Device Class : 2

Duns Number: 030899271

Premarket Exempt : No

Product Code : MEA, FRN

Prescription Use : Yes

Device Count : 1

Zyno - 00814371020365 Catalog Number : FE01

Device Description : Extension Set: 10" In-Line .22 Micron Filter, Slide Clamp. Extension Sets are s 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.

Device Class : 2

Duns Number: 030899271

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

Zyno - 00814371020389 Catalog Number : FE04

Device Description : Extension Set: 14" In-Line 1.2 Micron Filter, Slide Clamp. Extension Sets are s 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.

Device Class : 2

Duns Number: 030899271

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

Zyno - 00814371020433 Catalog Number : AX-80070

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

Device Class : 2

Duns Number: 030899271

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

Zyno - 00814371020440 Catalog Number : AX-80071-D

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

Device Class : 2

Duns Number: 030899271

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

Zyno - 00814371020457 Catalog Number : AX-80071-DF

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

Device Class : 2

Duns Number: 030899271

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

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