AFCS PEARLS™ Filter sheet large multifilament

Basic Information

• Brand Name: AFCS PEARLS™ Filter sheet large multifilament
• Primary DI: 08720387388042
• Version / Model: SAT2
• Catalog Number: 2010602
• Company Name: Synergie Nederland B.V.
• Labeler DUNS: 417294923
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-08-20
• Public Version: 1
• Public Version Date: 2021-08-30
• Public Version Status: New
• Public Device Record Key: 73ef0713-7de3-4f6d-becf-c2a2cde2e8d9

Device Description

Air-Fluidized bed - see www.synergiecare.com AFCS PEARLS™ (SAT2) Filter sheet large multifilament

Device Characteristics

• Single Use: No
• 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: No
• 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
INX	Bed, Air Fluidized	Physical Medicine	890.5160	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47455	Basic bed sheet, reusable	A large piece of fabric material intended to cover the mattress of a bed to protect it from being soiled and to provide the bed's occupant with clean, non-irritating contact surfaces (over and under); it does not include antimicrobial or nonadherent properties. It is typically made of a thin-textile or reinforced-paper material and is laundered for cleaning between periods of use. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08720387388042	GS1