ALLEN

Basic Information

• Brand Name: ALLEN
• Primary DI: 00615521014339
• Version / Model: 101002
• Catalog Number: F-FAS
• Company Name: HILL-ROM, INC.
• Labeler DUNS: 004245668
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-05-26
• Public Version: 3
• Public Version Date: 2024-09-30
• Public Version Status: Update
• Public Device Record Key: 9710b720-e0b2-46ed-8bcd-0d528b877a0b

Device Description

ANESTHESIA SCREEN, FLEXIBLE

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: 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
FWZ	Operating Room Accessories Table Tray	General, Plastic Surgery	878.4950	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35501	Anaesthesia screen	A frame-like device designed to provide a barrier between the sterile surgical site (i.e., where the surgeon operates) and the non-sterile area where the anaesthesiologists and other staff work during a procedure. It is typically fixed to the side rail of the operating table, and surgical drapes are hung over it or from it to create the hygienic partition. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00615521014339	GS1

Customer Contacts

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