AQUARI SURFACE SKYTRON 3500 3-PC

Basic Information

• Brand Name: AQUARI SURFACE SKYTRON 3500 3-PC
• Primary DI: 00842430115837
• Version / Model: 246-3500
• Catalog Number: 246-3500
• Company Name: MIZUHO ORTHOPEDIC SYSTEMS, INC.
• Labeler DUNS: 084527241
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-09
• Public Version: 2
• Public Version Date: 2022-05-12
• Public Version Status: Update
• Public Device Record Key: d8760818-7391-457c-8491-5cd156f9bfc4

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: Yes
• 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
FNM	Mattress, Air Flotation, Alternating Pressure	General Hospital	880.5550	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65167	Operating table patient pressure distribution monitoring/regulation system	An assembly of devices designed to monitor and regulate a patient’s body pressure distribution on an operating table mattress to reduce the risk of soft tissue strain and pressure injuries during a surgical procedure. The device consists of: 1) a pressure-sensing mattress which detects surface pressure distribution and feedbacks this information to; 2) an electrically-powered control/pump unit designed to analyse the patient’s volumetric shape variations and inflate/deflate the mattress accordingly.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00842430115837	GS1

Customer Contacts

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