Z-800 Z-800

GUDID 00814371020006

Large volume infusion pump

ZYNO MEDICAL LLC

General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered Bedside infusion pump Bedside infusion pump Bedside infusion pump Bedside infusion pump Bedside infusion pump Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel

• Primary Device ID: 00814371020006
• NIH Device Record Key: 94c7b833-845f-4e7f-b4eb-2fabcb4dbbdd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Z-800
• Version Model Number: Z-800
• Catalog Number: Z-800
• Company DUNS: 030899271
• Company Name: ZYNO MEDICAL LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 866-395-1988
• Email: support@zynomed.com
• Phone: 866-395-1988
• Email: support@zynomed.com
• Phone: 866-395-1988
• Email: support@zynomed.com
• Phone: 866-395-1988
• Email: support@zynomed.com
• Phone: 866-395-1988
• Email: support@zynomed.com
• Phone: 866-395-1988
• Email: support@zynomed.com
• Phone: 866-395-1988
• Email: support@zynomed.com
• Phone: 866-395-1988
• Email: support@zynomed.com
• Phone: 866-395-1988
• Email: support@zynomed.com
• Phone: 866-395-1988
• Email: support@zynomed.com
• Phone: 866-395-1988
• Email: support@zynomed.com
• Phone: 866-395-1988
• Email: support@zynomed.com
• Phone: 866-395-1988
• Email: support@zynomed.com
• Phone: 866-395-1988
• Email: support@zynomed.com
• Phone: 866-395-1988
• Email: support@zynomed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814371020006 [Primary]
GS1	10814371020003 [Package]; Package: Box [2 Units]; In Commercial Distribution
GS1	20814371020000 [Package]; Package: Box [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130690

FDA Product Code

• FRN: Pump, Infusion

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-13

Devices Manufactured by ZYNO MEDICAL LLC

• 00814371020006 - Z-800: 2018-07-06Large volume infusion pump
• 00814371020006 - Z-800: 2018-07-06 Large volume infusion pump
• 20814371020017 - Z-800F: 2018-07-06 Large volume infusion pump
• 20814371020024 - Z-800W: 2018-07-06 Large volume infusion pump
• 20814371020031 - Z-800WF: 2018-07-06 Large volume infusion pump
• 20814371020369 - Zyno: 2018-07-06 Extension Set: 10" In-Line .22 Micron Filter, Slide Clamp. Extension Sets are single-use IV administration sets for use with Z-
• 20814371020383 - Zyno: 2018-07-06 Extension Set: 14" In-Line 1.2 Micron Filter, Slide Clamp. Extension Sets are single-use IV administration setsfor use with Z-8
• 20814371020437 - Zyno: 2018-07-06 AX Primary Administration Set: 105" Straight Line Set, Roller Clamp. AX Primary Administration Sets are single-use IV administra
• 20814371020444 - Zyno: 2018-07-06 AX Administration Primary Set: 105" 1 NF Y-Site Below Pump, Roller Clamp. AX Primary Administration Sets are single-use IV admin