AVANOS

Basic Information

• Brand Name: AVANOS
• Primary DI: 00193494449476
• Version / Model: 44947
• Catalog Number: PM010-A-N
• Company Name: Avanos Medical, Inc.
• Labeler DUNS: 079375431
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-03
• Public Version: 1
• Public Version Date: 2020-07-13
• Public Version Status: New
• Public Device Record Key: 7fa0c8dd-edee-455c-beef-5dfc29aeb01c

Device Description

ON-Q* Antimicrobial Expansion Kits with SILVERSOAKER* Antimicrobial Catheter and NRFit™ Connector, SILVERSOAKER* 2.5 in. (65 mm), Needle 3.25 in. x 17 GA

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: No
• 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
BSO	CATHETER, CONDUCTION, ANESTHETIC	Anesthesiology	868.5120	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46383	Peripheral anaesthesia catheter set, non-medicated	A collection of devices intended for the continuous-administration of an anaesthetic agent (not included) to function as a peripheral nerve-block. It includes an anaesthesia needle and an anaesthesia catheter usually with additional devices utilized for the procedure (e.g., connectors, catheter holder). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10193494449473	GS1	CS	5	In Commercial Distribution
Primary	00193494449476	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K051401	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Catheter Soaker Length (in)
Length	2.5	Inch