Zyno FE01

GUDID 20814371020369

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.

ZYNO MEDICAL LLC

Intravenous administration tubing extension set

• Primary Device ID: 20814371020369
• NIH Device Record Key: 8285e118-70c2-4172-bacb-974297d7000b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zyno
• Version Model Number: FE01
• Catalog Number: FE01
• Company DUNS: 030899271
• Company Name: ZYNO MEDICAL LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814371020365 [Primary]
GS1	10814371020362 [Package]; Contains: 00814371020365; Package: [50 Units]; In Commercial Distribution
GS1	20814371020369 [Package]; Contains: 10814371020362; Package: [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120685

FDA Product Code

• FPA: Set, Administration, Intravascular

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

On-Brand Devices [Zyno]

• 20814371020604: Universal Secondary IV Administration Set: Use with all Z-800 Series Pumps, 40", Bag Hanger, Rol
• 20814371020581: BX Administration Primary Set: 105" 2 NF Y-Site, 1 Above, 1 Below Pump, .22 Filter, Back Check-V
• 20814371020574: BX Administration Primary Set: 105" 2 NF Y-Site, 1 Above, 1 Below Pump, Back Check-Valve, Anti-F
• 20814371020567: BX Administration Primary Set: 105" 1 NF Y-Site Above Pump, Back Check-Valve, Anti-Free Flow Cla
• 20814371020550: BX Administration Primary Set: 105" 1 NF Y Site Below Pump, 1.2 Filter, Anti-Free Flow Clamp. B
• 20814371020543: BX Administration Primary Set: 105" 1 NF Y-Site Below Pump, .22 Filter, Back Check-Valve, Anti-F
• 20814371020536: BX Administration Primary Set: 105" 1 NF Y-Site Below Pump, Anti-Free Flow Clamp. BX Primary Adm
• 20814371020529: BX Primary Administration Set: 105" Straight Line Set, Anti-Free Flow Clamp. BX Primary Administ
• 20814371020512: Universal Secondary IV Administration Set: Use with all Z-800 Series Pumps, 40", Bag Hanger, Rol
• 20814371020505: AX Administration Primary Set: 105" 2 NF Y-Site, 1 Below, 1 Above Pump, In-Line .22 Filter, Back
• 20814371020499: AX Administration Primary Set: 105" 2 NF Y-Site, 1 Above, 1 Below Pump, Back Check-Valve. AX Pri
• 20814371020482: AX Administration Primary Set: 105" 1 NF Y-Site Above Pump, In-line 0.22 Filter, Back Check-Valv
• 10814371020478: AX Administration Primary Set: 105" 1 NF Y Site above Pump, Back Check-Valve. AX Primary Adminis
• 20814371020468: AX Administration Primary Set: 105" 1 NF Y-Site Below Pump, In-line 1.2 Filter, Pinch Clamp. AX
• 20814371020451: AX Administration Primary Set: 105" 1 NF Y-Site Below Pump, In-line 0.22 Filter, Pinch Clamp. AX
• 20814371020444: AX Administration Primary Set: 105" 1 NF Y-Site Below Pump, Roller Clamp. AX Primary Administrat
• 20814371020437: AX Primary Administration Set: 105" Straight Line Set, Roller Clamp. AX Primary Administration S
• 20814371020383: Extension Set: 14" In-Line 1.2 Micron Filter, Slide Clamp. Extension Sets are single-use IV adm
• 20814371020369: Extension Set: 10" In-Line .22 Micron Filter, Slide Clamp. Extension Sets are single-use IV adm