ON-Q* Pain Relief System with ONDEMAND* Bolus Button, NRFit™ Connector PMB01-N

GUDID 10193494000063

Avanos Medical, Inc.

Des-gamma-carboxyprothrombin (DCP) IVD, calibrator Des-gamma-carboxyprothrombin (DCP) IVD, calibrator Des-gamma-carboxyprothrombin (DCP) IVD, calibrator Des-gamma-carboxyprothrombin (DCP) IVD, calibrator Des-gamma-carboxyprothrombin (DCP) IVD, calibrator Des-gamma-carboxyprothrombin (DCP) IVD, calibrator Des-gamma-carboxyprothrombin (DCP) IVD, calibrator Des-gamma-carboxyprothrombin (DCP) IVD, calibrator Des-gamma-carboxyprothrombin (DCP) IVD, calibrator Des-gamma-carboxyprothrombin (DCP) IVD, calibrator Des-gamma-carboxyprothrombin (DCP) IVD, calibrator Des-gamma-carboxyprothrombin (DCP) IVD, calibrator Des-gamma-carboxyprothrombin (DCP) IVD, calibrator Des-gamma-carboxyprothrombin (DCP) IVD, calibrator Des-gamma-carboxyprothrombin (DCP) IVD, calibrator Des-gamma-carboxyprothrombin (DCP) IVD, calibrator Des-gamma-carboxyprothrombin (DCP) IVD, calibrator
Primary Device ID10193494000063
NIH Device Record Keydc6b54df-c399-4677-9bb8-8ea724383662
Commercial Distribution StatusIn Commercial Distribution
Brand NameON-Q* Pain Relief System with ONDEMAND* Bolus Button, NRFit™ Connector
Version Model NumberPMB01-N
Catalog NumberPMB01-N
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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100193494000066 [Primary]
GS110193494000063 [Package]
Contains: 00193494000066
Package: CS [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MEBPump, infusion, elastomeric

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-03
Device Publish Date2023-06-23

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