ambIT* 220426

GUDID 00193494000677

PreSet* Pump (packaged)

Avanos Medical, Inc.

General-purpose infusion pump, battery-powered General-purpose infusion pump, battery-powered General-purpose infusion pump, battery-powered General-purpose infusion pump, battery-powered General-purpose infusion pump, battery-powered General-purpose infusion pump, battery-powered General-purpose infusion pump, battery-powered General-purpose infusion pump, battery-powered General-purpose infusion pump, battery-powered General-purpose infusion pump, battery-powered General-purpose infusion pump, battery-powered General-purpose infusion pump, battery-powered General-purpose infusion pump, battery-powered General-purpose infusion pump, battery-powered General-purpose infusion pump, battery-powered General-purpose infusion pump, battery-powered General-purpose infusion pump, battery-powered General-purpose infusion pump, battery-powered General-purpose infusion pump, battery-powered General-purpose infusion pump, battery-powered General-purpose infusion pump, battery-powered General-purpose infusion pump, battery-powered General-purpose infusion pump, battery-powered General-purpose infusion pump, battery-powered General-purpose infusion pump, battery-powered General-purpose infusion pump, battery-powered General-purpose infusion pump, battery-powered General-purpose infusion pump, battery-powered General-purpose infusion pump, battery-powered General-purpose infusion pump, battery-powered General-purpose infusion pump, battery-powered General-purpose infusion pump, battery-powered General-purpose infusion pump, battery-powered Ambulatory non-insulin infusion pump, electric Ambulatory non-insulin infusion pump, electric Ambulatory non-insulin infusion pump, electric Ambulatory non-insulin infusion pump, electric Ambulatory non-insulin infusion pump, electric Ambulatory non-insulin infusion pump, electric Ambulatory non-insulin infusion pump, electric Ambulatory non-insulin infusion pump, electric Ambulatory non-insulin infusion pump, electric Ambulatory non-insulin infusion pump, electric Ambulatory non-insulin infusion pump, electric Ambulatory non-insulin infusion pump, electric Ambulatory non-insulin infusion pump, electric Ambulatory non-insulin infusion pump, electric Ambulatory non-insulin infusion pump, electric Ambulatory non-insulin infusion pump, electric Ambulatory non-insulin infusion pump, electronic Ambulatory non-insulin infusion pump, electronic Ambulatory non-insulin infusion pump, electronic Ambulatory non-insulin infusion pump, electronic Ambulatory non-insulin infusion pump, electronic Ambulatory non-insulin infusion pump, electronic Ambulatory non-insulin infusion pump, electronic Ambulatory non-insulin infusion pump, electronic Ambulatory non-insulin infusion pump, electronic Ambulatory non-insulin infusion pump, electronic Ambulatory non-insulin infusion pump, electronic Ambulatory non-insulin infusion pump, electronic Ambulatory non-insulin infusion pump, electronic
Primary Device ID00193494000677
NIH Device Record Key8064f688-d1b4-4856-8414-1ee4a9fe24d2
Commercial Distribution StatusIn Commercial Distribution
Brand NameambIT*
Version Model Number220426
Catalog Number220426
Company DUNS079375431
Company NameAvanos Medical, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS100193494000677 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FRNPump, infusion
OFQAnesthesia kit

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-15
Device Publish Date2022-02-07

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20193494001289ambIT* Pain Control System - Spike Cassette with Filter
20193494001272ambIT* Pain Control System - Male Luer Cassette with Filter
20193494001265ambIT* Pain Control Kit - Spike Cassette with Filter
20193494001258ambIT* Pain Control Kit - Male Luer Cassette with Filter
20193494001067ambIT* Chemotherapy Kit
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20193494001005ambIT* Pain Control Kit - Basic w/ Male Filter Cassette
20193494000985ambIT* Pain Control Kit - Basic
20193494000978ambIT* Pain Control Kit – Basic with 420mL MediBag*
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20193494000947ambIT* Pain Control Kit - Basic w/Filterless Male Luer Cass
20193494000930ambIT* Pain Control Kit - Basic w/Male Filter Cassette
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20193494000855ambIT* Pain Control System - Basic
20193494000848ambIT* Pain Control System - Basic w/Filter Spike Cassette
20193494000831ambIT* Pain Control Kit - Basic w/Filterless Male Luer Cassette
20193494000824ambIT* Pain Control System - Standard
20193494000756ambIT* Pain Control System - PIB/PCA
20193494000640ambIT* Pain Control System - RA PreSet*
20193494000619ambIT* Introducer - Beveled Tip, Peelable Sheath
20193494000367ambIT* RPS Kit-Spike Cassette with Filter
20193494000350ambIT* RPS Kit-Male Luer Cassette with Filter *

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