ON-Q* Pain Relief System with Dual SILVERSOAKER* Antimicrobial Catheters PS6505-A-N

GUDID 10193494000124

Avanos Medical, Inc.

Hyaluronic acid (HA) IVD, control Hyaluronic acid (HA) IVD, control Hyaluronic acid (HA) IVD, control Hyaluronic acid (HA) IVD, control Hyaluronic acid (HA) IVD, control Hyaluronic acid (HA) IVD, control Hyaluronic acid (HA) IVD, control Hyaluronic acid (HA) IVD, control Hyaluronic acid (HA) IVD, control Hyaluronic acid (HA) IVD, control Hyaluronic acid (HA) IVD, control Hyaluronic acid (HA) IVD, control Hyaluronic acid (HA) IVD, control Hyaluronic acid (HA) IVD, control Hyaluronic acid (HA) IVD, control Hyaluronic acid (HA) IVD, control Hyaluronic acid (HA) IVD, control
Primary Device ID10193494000124
NIH Device Record Keyc6c014ea-6e56-46d4-9e3b-0a4946cd9c92
Commercial Distribution StatusIn Commercial Distribution
Brand NameON-Q* Pain Relief System with Dual SILVERSOAKER* Antimicrobial Catheters
Version Model NumberPS6505-A-N
Catalog NumberPS6505-A-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
GS100193494000127 [Primary]
GS110193494000124 [Package]
Contains: 00193494000127
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

Devices Manufactured by Avanos Medical, Inc.

10193493000750 - GenVisc 850 Sodium Hyaluronate2024-03-14 GenVisc 850
10193493000767 - TriVisc Sodium Hyaluronate2024-03-14 TriVisc
00193494000646 - ambiT® "PreSet" Ambulatory Infusion Pump2024-03-07 ambIT* Pain Control System - RA PreSet*
00193494000837 - ambiT® "PreSet" Ambulatory Infusion Pump2024-03-07 ambIT* Pain Control Kit - Basic w/Filterless Male Luer Cassette
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

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