ambIT* Pain Control System 220471

GUDID 20193494000886

ambIT* Pain Control System - 5in Uni-Flo*Fenestrated Catheter

Avanos Medical, Inc.

Infusion pump/catheter analgesia administration kit Infusion pump/catheter analgesia administration kit Infusion pump/catheter analgesia administration kit Infusion pump/catheter analgesia administration kit Infusion pump/catheter analgesia administration kit Infusion pump/catheter analgesia administration kit Infusion pump/catheter analgesia administration kit Infusion pump/catheter analgesia administration kit Infusion pump/catheter analgesia administration kit Infusion pump/catheter analgesia administration kit Infusion pump/catheter analgesia administration kit Infusion pump/catheter analgesia administration kit Infusion pump/catheter analgesia administration kit Infusion pump/catheter analgesia administration kit Infusion pump/catheter analgesia administration kit Infusion pump/catheter analgesia administration kit Infusion pump/catheter analgesia administration kit Infusion pump/catheter analgesia administration kit
Primary Device ID20193494000886
NIH Device Record Keyf5c528c4-099d-44d5-b70d-f51fe32b7606
Commercial Distribution StatusIn Commercial Distribution
Brand NameambIT* Pain Control System
Version Model Number220471
Catalog Number220471
Company DUNS079375431
Company NameAvanos Medical, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100193494000882 [Primary]
GS120193494000886 [Package]
Contains: 00193494000882
Package: CS [5 Units]
In Commercial Distribution

FDA Product Code

OFQAnesthesia kit

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-16
Device Publish Date2023-10-06

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00193494000844 - ambiT® "PreSet" Ambulatory Infusion Pump2024-03-07 ambIT* Pain Control System - Basic w/Filter Spike Cassette
00193494000851 - ambiT® "PreSet" Ambulatory Infusion Pump2024-03-07 ambIT* Pain Control System - Basic
00193494001285 - ambiT® "PreSet" Ambulatory Infusion Pump2024-03-07 ambIT* Pain Control System - Spike Cassette with Filter
00193494001292 - ambIT* PIB-PCA v1.5 System w/Male Filter Cass2024-03-07 ambIT* PIB-PCA v1.5 System w/Male Filter Cass
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