ambIT* Remote Bolus Switch 220265

GUDID 20193494000770

Remote Bolus Switch

Avanos Medical, Inc.

Infusion pump remote control Infusion pump remote control Infusion pump remote control Infusion pump remote control Infusion pump remote control Infusion pump remote control Infusion pump remote control Infusion pump remote control Infusion pump remote control Infusion pump remote control Infusion pump remote control Infusion pump remote control Infusion pump remote control Infusion pump remote control Infusion pump remote control Infusion pump remote control Infusion pump remote control Infusion pump remote control

• Primary Device ID: 20193494000770
• NIH Device Record Key: d68e1789-e428-45ea-9b28-2520323e8b2f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ambIT* Remote Bolus Switch
• Version Model Number: 220265
• Catalog Number: 220265
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• 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
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00193494000776 [Primary]
GS1	20193494000770 [Package]; Contains: 00193494000776; Package: CS [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162165

FDA Product Code

• MEA: Pump, infusion, pca

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-13
• Device Publish Date: 2023-04-05

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• 00193494000837 - ambiT® "PreSet" Ambulatory Infusion Pump: 2024-03-07 ambIT* Pain Control Kit - Basic w/Filterless Male Luer Cassette
• 00193494000844 - ambiT® "PreSet" Ambulatory Infusion Pump: 2024-03-07 ambIT* Pain Control System - Basic w/Filter Spike Cassette
• 00193494000851 - ambiT® "PreSet" Ambulatory Infusion Pump: 2024-03-07 ambIT* Pain Control System - Basic
• 00193494001285 - ambiT® "PreSet" Ambulatory Infusion Pump: 2024-03-07 ambIT* Pain Control System - Spike Cassette with Filter
• 00193494001292 - ambIT* PIB-PCA v1.5 System w/Male Filter Cass: 2024-03-07 ambIT* PIB-PCA v1.5 System w/Male Filter Cass