CATALYST BARIATRIC BED

Basic Information

• Brand Name: CATALYST BARIATRIC BED
• Primary DI: 00850520008020
• Version / Model: ASM100112
• Company Name: KREG MEDICAL INC.
• Labeler DUNS: 079220324
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-21
• Public Version: 1
• Public Version Date: 2018-10-22
• Public Version Status: New
• Public Device Record Key: d8960d92-7acc-4bff-a641-e7185650e934

Device Description

Hospital Bariatric Bed with Standing Frame and Drive

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: 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
FNL	Bed, Ac-Powered Adjustable Hospital	General Hospital	880.5100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37201	Stand-up bed	A mains electricity (AC-powered), motorized bed used for a person with a disability or a bedridden patient to enable them to acheive a standing position whilst being held in the bed. It can be raised from a horizontal (flat) to a vertical (standing) position and helps prevent undesirable effects, e.g., pressure sores; contracture in the hip, knee and ankle joints; or deterioration of cardio-circulatory and respiratory performance.	No	Active
34870	Basic electric hospital bed	A mains electricity (AC-powered) bed designed to be used as a patient bed for rest/sleep in a hospital ward/room, and which is motorized providing the patient/nursing staff with touch button adjustment possibilities. It typically includes a framework with wheels, a mattress support platform that can articulate, a headboard and footboard, siderails, and a remote control to operate the electrical motors. It may have an integrated weighing scale.	No	Active
32153	Bed mattress support platform, electric	A mains electricity (AC-powered) medical bed structure that supports a medical bed patient surface (e.g., a mattress) and that can articulate and/or change its surface to facilitate various therapeutic, diagnostic, and convenience positions. It is typically a flat structure made of a metal frame that operates in response to an electrically-operated bed control device.	No	Active
35563	Bariatric bed	A mains electricity (AC-powered) bed specifically designed as a bed to accommodate a bariatric (obese) patient whose body mass exceeds the safe working load of standard hospital/institution beds and trolleys, i.e., 500 kg total, including the weight of the mattress and other accessories. Features like size, shape, and patient comfort (both physical and mental) will be taken into consideration by the design. This device is electrically-operated to assist the user/attending staff to adjust the functions and positions of the bed. It will typically include adjustable height, back rest, knee-break, removable head and foot ends and possibly an integrated weighing facility.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850520008020	GS1

Customer Contacts

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