ambIT* DISPOSABLE PLUS

Basic Information

• Brand Name: ambIT* DISPOSABLE PLUS
• Primary DI: 00193494001988
• Version / Model: 120008769
• Catalog Number: 220578
• Company Name: Avanos Medical, Inc.
• Labeler DUNS: 079375431
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-08-27
• Public Version: 1
• Public Version Date: 2025-09-04
• Public Version Status: New
• Public Device Record Key: b280cd0b-3197-4363-9b52-dabff8a81485

Device Description

ambIT* DISPOSABLE PLUS

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: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MEA	Pump, infusion, pca	General Hospital	880.5725	2
FRN	Pump, infusion	General Hospital	880.5725	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61514	Ambulatory non-insulin infusion pump, electronic	A battery-powered ambulatory device intended to provide continuous or intermittent administration of medication, commonly for antibiotic therapy, chemotherapy, or patient-controlled analgesia (PCA); it is not dedicated to insulin infusion. It consists of a small unit with a pumping mechanism and an infusion-rate controller. It is used with a dedicated single-use medication cartridge and/or an injection/infusion set for delivery via an intravenous, subcutaneous, arterial, epidural or intracavital route. It is typically worn in a case attached to the belt, carried in a pocket or bag, for ambulation within and outside healthcare settings; it may be designed for optional pole mounting.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10193494001985	GS1	CS	5	In Commercial Distribution
Primary	00193494001988	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K162165	000