Z-800W Z-800W

GUDID 20814371020024

Large volume infusion pump

ZYNO MEDICAL LLC

General-purpose infusion pump, line-powered
Primary Device ID20814371020024
NIH Device Record Key7d992489-cc7c-41d1-972c-d89039707c14
Commercial Distribution StatusIn Commercial Distribution
Brand NameZ-800W
Version Model NumberZ-800W
Catalog NumberZ-800W
Company DUNS030899271
Company NameZYNO MEDICAL LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone866-395-1988
Emailsupport@zynomed.com
Phone866-395-1988
Emailsupport@zynomed.com
Phone866-395-1988
Emailsupport@zynomed.com
Phone866-395-1988
Emailsupport@zynomed.com
Phone866-395-1988
Emailsupport@zynomed.com
Phone866-395-1988
Emailsupport@zynomed.com
Phone866-395-1988
Emailsupport@zynomed.com
Phone866-395-1988
Emailsupport@zynomed.com
Phone866-395-1988
Emailsupport@zynomed.com
Phone866-395-1988
Emailsupport@zynomed.com
Phone866-395-1988
Emailsupport@zynomed.com
Phone866-395-1988
Emailsupport@zynomed.com
Phone866-395-1988
Emailsupport@zynomed.com
Phone866-395-1988
Emailsupport@zynomed.com
Phone866-395-1988
Emailsupport@zynomed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100814371020020 [Primary]
GS110814371020027 [Package]
Contains: 00814371020020
Package: box [2 Units]
In Commercial Distribution
GS120814371020024 [Package]
Contains: 00814371020020
Package: box [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FRNPump, Infusion

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-13

Devices Manufactured by ZYNO MEDICAL LLC

00814371020006 - Z-8002018-07-06 Large volume infusion pump
20814371020017 - Z-800F2018-07-06 Large volume infusion pump
20814371020024 - Z-800W2018-07-06Large volume infusion pump
20814371020024 - Z-800W2018-07-06 Large volume infusion pump
20814371020031 - Z-800WF2018-07-06 Large volume infusion pump
20814371020369 - Zyno2018-07-06 Extension Set: 10" In-Line .22 Micron Filter, Slide Clamp. Extension Sets are single-use IV administration sets for use with Z-
20814371020383 - Zyno2018-07-06 Extension Set: 14" In-Line 1.2 Micron Filter, Slide Clamp. Extension Sets are single-use IV administration setsfor use with Z-8
20814371020437 - Zyno2018-07-06 AX Primary Administration Set: 105" Straight Line Set, Roller Clamp. AX Primary Administration Sets are single-use IV administra
20814371020444 - Zyno2018-07-06 AX Administration Primary Set: 105" 1 NF Y-Site Below Pump, Roller Clamp. AX Primary Administration Sets are single-use IV admin

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