Getinge Aquadis 56

Basic Information

• Brand Name: Getinge Aquadis 56
• Primary DI: 07340153710351
• Version / Model: 56M
• Company Name: Getinge Disinfection AB
• Labeler DUNS: 354023236
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-23
• Public Version: 1
• Public Version Date: 2023-01-02
• Public Version Status: New
• Public Device Record Key: 45dc7e6c-74d6-4bf7-9e30-fc5dd7ca3b86

Device Description

Washer disinfector

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: Yes
• Has Lot/Batch Number: No
• 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
MEC	Disinfector, Medical Devices	General Hospital	880.6992	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35424	Surgical utensil washer/disinfector	A mains electricity (AC-powered) unit designed to wash (remove dirt/stains), decontaminate (remove organic debris), and disinfect (destroy microorganisms) reusable surgical instruments, bowls, anaesthesia equipment components, and some surgical footwear. Most instruments, especially those used invasively or in a sterile field will require sterilization after this process. It is typically located in rooms and central supply departments designed to handle soiled instruments/utensils. It typically includes internal baskets/racks in which the utensils are placed to ensure circulation of the heated water/detergents to all surfaces.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07340153710351	GS1