ON-Q* Pain Relief System with SELECT-A-FLOW PSAF02-N

GUDID 10193494000148

Avanos Medical, Inc.

Des-gamma-carboxyprothrombin (DCP) IVD, control

• Primary Device ID: 10193494000148
• NIH Device Record Key: 592c4df0-2ee0-4896-98b1-9886b79f864c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ON-Q* Pain Relief System with SELECT-A-FLOW
• Version Model Number: PSAF02-N
• Catalog Number: PSAF02-N
• Company DUNS: 079375431
• Company Name: Avanos Medical, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00193494000141 [Primary]
GS1	10193494000148 [Package]; Contains: 00193494000141; Package: CS [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063530

FDA Product Code

• MEB: Pump, infusion, elastomeric

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-03
• Device Publish Date: 2023-06-23

Devices Manufactured by Avanos Medical, Inc.

• 10350770006014 - MIC GASTRO-ENTEROSTOMY TUBE MODIFICATION: 2024-12-25 MIC* Gastric-Jejunal Feeding Tube Kit with ENFit® Connector - Surgical Placement - 22 Fr
• 10350770006021 - MIC GASTRO-ENTEROSTOMY TUBE MODIFICATION: 2024-12-25 MIC* Gastric-Jejunal Feeding Tube Kit with ENFit® Connector - Surgical Placement - 16 Fr
• 10350770006038 - MIC GASTRO-ENTEROSTOMY TUBE MODIFICATION: 2024-12-25 MIC* Gastric-Jejunal Feeding Tube Kit with ENFit® Connector - Surgical Placement - 18 Fr
• 10350770006045 - MIC* Gastric - Jejunal Feeding Tube Kit: 2024-12-25 MIC* Gastric-Jejunal Feeding Tube Kit - Surgical Placement - 16 Fr
• 10350770006052 - MIC* Gastric - Jejunal Feeding Tube Kit: 2024-12-25 MIC* Gastric-Jejunal Feeding Tube Kit - Surgical Placement - 22 Fr
• 10350770006069 - MIC* Gastric - Jejunal Feeding Tube Kit: 2024-12-25 MIC* Gastric-Jejunal Feeding Tube Kit - Surgical Placement - 18 Fr
• 10350770005604 - CORGRIP* SR NG/NI Tube Retention System: 2024-11-14 CORGRIP* SR Nasogastric/Nasointestinal Feeding Tube Retention System
• 10350770005611 - CORGRIP* SR NG/NI Tube Retention System: 2024-11-14 CORGRIP* SR Nasogastric/Nasointestinal Feeding Tube Retention System