80540 OASIS - Antifatigue Mat with Absorbent 8mm (yellow material) Inner Layer

Basic Information

• Brand Name: 80540 OASIS - Antifatigue Mat with Absorbent 8mm (yellow material) Inner Layer
• Primary DI: 00787551003024
• Version / Model: 80540
• Catalog Number: 80540
• Company Name: XODUS MEDICAL, INC.
• Labeler DUNS: 868042664
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-08
• Public Version: 1
• Public Version Date: 2022-12-16
• Public Version Status: New
• Public Device Record Key: 5893d9f0-94b1-4955-820f-a840867beba0

Device Description

80540 OASIS - Antifatigue Mat with Absorbent 8mm (yellow material) Inner Layer

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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
FRL	FIBER, MEDICAL, ABSORBENT	General Hospital	880.5300	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61850	Absorbent underpad, non-antimicrobial, single-use	A flat piece of absorbent fabric material [e.g., non-woven polyethylene (PE), cellulose] intended to be placed on a surface (e.g., bed mattress, table, floor) and underneath a patient to absorb bodily fluids resulting from surgical procedures, childbirth and/or incontinence; it does not include an antimicrobial agent(s). It is intended to be used in the healthcare facility and in the home. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20787551003028	GS1	CASE	8	In Commercial Distribution
Primary	00787551003024	GS1

Customer Contacts

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