ambIT* Pain Control System

Basic Information

• Brand Name: ambIT* Pain Control System
• Primary DI: 00193494000882
• Version / Model: 220471
• Catalog Number: 220471
• Company Name: Avanos Medical, Inc.
• Labeler DUNS: 079375431
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-06
• Public Version: 1
• Public Version Date: 2023-10-16
• Public Version Status: New
• Public Device Record Key: f5c528c4-099d-44d5-b70d-f51fe32b7606

Device Description

ambIT* Pain Control System - 5in Uni-Flo*Fenestrated Catheter

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OFQ	Anesthesia kit	Anesthesiology	868.5120	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66375	Infusion pump/catheter analgesia administration kit	A collection of devices which includes a battery-powered ambulatory infusion pump and a percutaneous short-term (<= 30 days) perineural catheter intended for delivery of an anaesthetic/analgesic agent (not included) adjacent to a peripheral nerve or at a wound site for nerve-block/pain management. In addition to the pump and catheter the kit typically includes pump components (e.g., cartridge, pump bag) and disposable devices intended to for catheter introduction (e.g., introducer assembly). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20193494000886	GS1	CS	5	In Commercial Distribution
Primary	00193494000882	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]