SARA STEDY

Basic Information

• Brand Name: SARA STEDY
• Primary DI: 05055982773683
• Version / Model: NTB2000
• Company Name: Arjohuntleigh AB
• Labeler DUNS: 355804758
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-07-27
• Public Version: 1
• Public Version Date: 2022-08-04
• Public Version Status: New
• Public Device Record Key: a9d1ab4b-b5ce-4d58-8bcd-34c917bbe624

Device Description

SARA STEDY - Standing and raising aid

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: 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
INM	Chair, With Casters	Physical Medicine	890.3100	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45678	Mobile patient lifting system, manual	A non-powered, mobile assembly of devices designed to enable one person to lift and move an incapacitated patient or a person with a disability safely and with minimal physical effort. Also known as a patient hoist, it typically consists of a support base on wheels with a lifting mechanism, mast, boom, swivel bar, and patient holding device (e.g., a sling, holder or a frame). The lifting mechanism provides mechanical advantage (e.g., using pneumatic springs) to aid manual movement of components. It is typically used to lift and move the occupant in a sitting or semi-sitting position over short distances within the treatment facility, e.g., from a bed to a bathroom.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05055982773683	GS1