ambIT* 220527

GUDID 00193494000769

PIB*IL Pump

Avanos Medical, Inc.

General-purpose infusion pump, battery-powered
Primary Device ID00193494000769
NIH Device Record Keya4e0107c-d15b-4b6e-b7b6-a565b466cf43
Commercial Distribution StatusIn Commercial Distribution
Brand NameambIT*
Version Model Number220527
Catalog Number220527
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
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
GS100193494000769 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FRNPump, infusion

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

On-Brand Devices [ambIT*]

20193494001180ambIT* Cassette - Filter, Male Luer
20193494001166ambIT* Cassette - Filter, Spike
10193494001152ambIT* Cassette - Filter, Spike
10193494001145ambIT* Cassette - Filter, Spike, and Neuraxial Connector
20193494001128ambIT* Cassette - Filter, Spike with Yellow Stripe Tubing
10193494001114ambIT* Cassette - Filter, Spike with Yellow Striped Tubing
20193494001104ambIT* Cassette - Filter, Spike with Yellow Striped Tubing, and Neuraxial Connector
10193494001091ambIT* Cassette - Filterless, Male Luer
10193494001084ambIT* Cassette - Filterless, Spike
20193494000381ambIT* Cassette - Filter, Male Neuraxial Connector
00193494001384PIB IL v 1.5
00193494001216KIDS PIB Pump-Blue
00193494001049Continuous Pump
00193494000998Military PCA Pump
00193494000813PCA Pump
00193494000769PIB*IL Pump
00193494000707PIB-PCA Pump
00193494000684PreSet* *PCA Pump
00193494000677PreSet* Pump (packaged)
20193494001470ambIT* PreSet* v1.5 System w/Male Filter Cass
20193494001487ambIT* PreSet* v1.5 System w/Spike Filter Cass
20193494001302ambIT* PIB-PCA v1.5 System w/Spike Filter Cass
20193494001296ambIT* PIB-PCA v1.5 System w/Male Filter Cass
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
20193494001050ambIT Single Chemotherapy Kit
20193494001036ambIT* Epidural Kit
20193494001005ambIT* Pain Control Kit - Basic w/ Male Filter Cassette
20193494000985ambIT* Pain Control Kit - Basic
20193494000978ambIT* Pain Control Kit – Basic with 420mL MediBag*
20193494000961ambIT* Pain Control Kit - Basic w/420mL MediBag* & Shipper Cap
20193494000954ambIT* Pain Control Kit - Basic w/Filter Spike Cassette
20193494000947ambIT* Pain Control Kit - Basic w/Filterless Male Luer Cass
20193494000930ambIT* Pain Control Kit - Basic w/Male Filter Cassette
20193494000923ambIT* Pain Control Kit - Basic with Shipper Cap
20193494000916ambIT* Pain Control Kit - Standard
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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