AQUALGEL

Basic Information

• Brand Name: AQUALGEL
• Primary DI: 00724995219857
• Version / Model: BF474
• Catalog Number: BF474
• Company Name: STERIS CORPORATION
• Labeler DUNS: 036985604
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-01
• Public Version: 1
• Public Version Date: 2022-12-09
• Public Version Status: New
• Public Device Record Key: 63a40f61-345d-4018-91ca-60d7706ecbde

Device Description

AQUAGEL Sacral Protector, Small is a 3-dimensional positioner that re-distributes pressure away from the sacrum and is ideal for all supine patients, especially those in the Lithotomy position .

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: 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
LWG	SURGICAL TABLE CUSHION	General, Plastic Surgery	878.4950	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31684	Operating table patient pressure distribution pad, reusable	A cushion (e.g., gel-filled, foam) intended to be placed between an operating table mattress or a patient positioner (e.g., torso intraoperative positioner, perineal post) and the patient to distribute the patient's body weight over a large surface area, for the prevention of pressure sores and tissue necrosis on prominent parts of the patient's body when immobilized for extended periods during surgery. It is available in various dimensions and shapes to accommodate various body parts such as the buttocks, shoulders, heels, or the entire body (usually excluding the head). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00724995219857	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -18 – 50 Degrees Celsius