ambIT* 220534

GUDID 00193494000684

PreSet* *PCA Pump

Avanos Medical, Inc.

Peripheral vascular infusion catheter

• Primary Device ID: 00193494000684
• NIH Device Record Key: 5024d225-451a-402c-820c-12f4e1826d38
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ambIT*
• Version Model Number: 220534
• Catalog Number: 220534
• 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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
• 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
• 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	00193494000684 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052221

FDA Product Code

• FRN: Pump, infusion
• OFQ: Anesthesia kit

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: 2022-02-15
• Device Publish Date: 2022-02-07

On-Brand Devices [ambIT*]

• 20193494001180: ambIT* Cassette - Filter, Male Luer
• 20193494001166: ambIT* Cassette - Filter, Spike
• 10193494001152: ambIT* Cassette - Filter, Spike
• 10193494001145: ambIT* Cassette - Filter, Spike, and Neuraxial Connector
• 20193494001128: ambIT* Cassette - Filter, Spike with Yellow Stripe Tubing
• 10193494001114: ambIT* Cassette - Filter, Spike with Yellow Striped Tubing
• 20193494001104: ambIT* Cassette - Filter, Spike with Yellow Striped Tubing, and Neuraxial Connector
• 10193494001091: ambIT* Cassette - Filterless, Male Luer
• 10193494001084: ambIT* Cassette - Filterless, Spike
• 20193494000381: ambIT* Cassette - Filter, Male Neuraxial Connector
• 00193494001384: PIB IL v 1.5
• 00193494001216: KIDS PIB Pump-Blue
• 00193494001049: Continuous Pump
• 00193494000998: Military PCA Pump
• 00193494000813: PCA Pump
• 00193494000769: PIB*IL Pump
• 00193494000707: PIB-PCA Pump
• 00193494000684: PreSet* *PCA Pump
• 00193494000677: PreSet* Pump (packaged)
• 20193494001470: ambIT* PreSet* v1.5 System w/Male Filter Cass
• 20193494001487: ambIT* PreSet* v1.5 System w/Spike Filter Cass
• 20193494001302: ambIT* PIB-PCA v1.5 System w/Spike Filter Cass
• 20193494001296: ambIT* PIB-PCA v1.5 System w/Male Filter Cass
• 20193494001289: ambIT* Pain Control System - Spike Cassette with Filter
• 20193494001272: ambIT* Pain Control System - Male Luer Cassette with Filter
• 20193494001265: ambIT* Pain Control Kit - Spike Cassette with Filter
• 20193494001258: ambIT* Pain Control Kit - Male Luer Cassette with Filter
• 20193494001067: ambIT* Chemotherapy Kit
• 20193494001050: ambIT Single Chemotherapy Kit
• 20193494001036: ambIT* Epidural Kit
• 20193494001005: ambIT* Pain Control Kit - Basic w/ Male Filter Cassette
• 20193494000985: ambIT* Pain Control Kit - Basic
• 20193494000978: ambIT* Pain Control Kit – Basic with 420mL MediBag*
• 20193494000961: ambIT* Pain Control Kit - Basic w/420mL MediBag* & Shipper Cap
• 20193494000954: ambIT* Pain Control Kit - Basic w/Filter Spike Cassette
• 20193494000947: ambIT* Pain Control Kit - Basic w/Filterless Male Luer Cass
• 20193494000930: ambIT* Pain Control Kit - Basic w/Male Filter Cassette
• 20193494000923: ambIT* Pain Control Kit - Basic with Shipper Cap
• 20193494000916: ambIT* Pain Control Kit - Standard
• 20193494000855: ambIT* Pain Control System - Basic
• 20193494000848: ambIT* Pain Control System - Basic w/Filter Spike Cassette
• 20193494000831: ambIT* Pain Control Kit - Basic w/Filterless Male Luer Cassette
• 20193494000824: ambIT* Pain Control System - Standard
• 20193494000756: ambIT* Pain Control System - PIB/PCA
• 20193494000640: ambIT* Pain Control System - RA PreSet*
• 20193494000619: ambIT* Introducer - Beveled Tip, Peelable Sheath
• 20193494000367: ambIT* RPS Kit-Spike Cassette with Filter
• 20193494000350: ambIT* RPS Kit-Male Luer Cassette with Filter *