ON-Q* CB002

GUDID 10193494134690

ON-Q* Pump Fixed Flow

Avanos Medical, Inc.

Elastomeric infusion pump system

• Primary Device ID: 10193494134690
• NIH Device Record Key: 92ffa1f2-6dbb-462d-b259-d8a4dbe1fd87
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ON-Q*
• Version Model Number: CB002
• Catalog Number: CB002
• 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: false
• 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
• 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 Dimensions

• Length: 400 Centimeter
• Length: 400 Centimeter
• Length: 400 Centimeter
• Length: 400 Centimeter
• Length: 400 Centimeter
• Length: 400 Centimeter
• Length: 400 Centimeter
• Length: 400 Centimeter
• Length: 400 Centimeter
• Length: 400 Centimeter
• Length: 400 Centimeter
• Length: 400 Centimeter
• Length: 400 Centimeter
• Length: 400 Centimeter
• Length: 400 Centimeter
• Length: 400 Centimeter
• Length: 400 Centimeter
• Length: 400 Centimeter
• Length: 400 Centimeter
• Length: 400 Centimeter
• Length: 400 Centimeter
• Length: 400 Centimeter
• Length: 400 Centimeter
• Length: 400 Centimeter
• Length: 400 Centimeter
• Length: 400 Centimeter
• Length: 400 Centimeter
• Length: 400 Centimeter
• Length: 400 Centimeter
• Length: 400 Centimeter
• Length: 400 Centimeter
• Length: 400 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00193494134693 [Primary]
GS1	10193494134690 [Package]; Contains: 00193494134693; 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: 2021-02-04
• Device Publish Date: 2021-01-27

On-Brand Devices [ON-Q*]

• 10193494136106: ON-Q* Pump with Select-A-Flow*
• 10193494136052: ON-Q* Pump with ONDEMAND*
• 10193494134690: ON-Q* Pump Fixed Flow
• 10193494135345: ON-Q* Catheters-Soaker*
• 10193494471863: AVANOS* Filling Extension Set