AVANOS

Basic Information

• Brand Name: AVANOS
• Primary DI: 00350770469218
• Version / Model: 46921
• Catalog Number: EDS-250
• Company Name: Avanos Medical, Inc.
• Labeler DUNS: 079375431
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-02-17
• Public Version: 2
• Public Version Date: 2020-04-03
• Public Version Status: Update
• Public Device Record Key: 89d32442-daf5-48e3-9ff4-f5ebebaec468

Device Description

Enteral Drainage System

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FFD	EVACUATOR, BLADDER, MANUALLY OPERATED	Gastroenterology, Urology	876.4370	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62286	Gastric drainage/decompression bag	A plastic sac intended to be used to collect stomach contents during gastric drainage/decompression, via an enteral tube (not included), to drain/empty stomach contents (e.g., prior to surgery, as therapy for obstructed bowel). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10350770469215	GS1	CS	30	In Commercial Distribution
Primary	00350770469218	GS1

Customer Contacts

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