ambIT* PIB-PCA v1.5 System w/Male Filter Cass 220573

GUDID 00193494001292

ambIT* PIB-PCA v1.5 System w/Male Filter Cass

Avanos Medical, Inc.

Ambulatory non-insulin infusion pump, electronic
Primary Device ID00193494001292
NIH Device Record Key68fc3273-ac60-42de-94d2-1ce37843a4f1
Commercial Distribution StatusIn Commercial Distribution
Brand NameambIT* PIB-PCA v1.5 System w/Male Filter Cass
Version Model Number220573
Catalog Number220573
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 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
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
GS100193494001292 [Primary]
GS110193494001299 [Package]
Package: CS [5 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 Number2
Public Version Date2024-03-07
Device Publish Date2022-11-04

Devices Manufactured by Avanos Medical, Inc.

10350770005758 - Corpgrip NG/NI tube retention system2024-08-22 CORGRIP* NG/NI Feeding Tube Retention System, For Use with Salem Sump Tubes
10350770005765 - Corpgrip NG/NI tube retention system2024-08-22 CORGRIP* Nasogastric/Nasointestinal Feeding Tube Retention System
10350770005772 - Corpgrip NG/NI tube retention system2024-08-22 CORGRIP* Nasogastric/Nasointestinal Feeding Tube Retention System
10350770005789 - Corpgrip NG/NI tube retention system2024-08-22 CORGRIP* Nasogastric/Nasointestinal Feeding Tube Retention System
10350770005796 - Corpgrip NG/NI tube retention system2024-08-22 CORGRIP* Nasogastric/Nasointestinal Feeding Tube Retention System
10350770005802 - Corpgrip NG/NI tube retention system2024-08-22 CORGRIP* Nasogastric/Nasointestinal Feeding Tube Retention System
30680651929205 - Halyard2024-06-12 HYH,UBLOCK,UBT,-,-,10
10193493000750 - GenVisc 850 Sodium Hyaluronate2024-03-14 GenVisc 850

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.