Carmina

Basic Information

• Brand Name: Carmina
• Primary DI: 05055982786980
• Version / Model: BLB2000-013
• Company Name: Arjohuntleigh AB
• Labeler DUNS: 355804758
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-07-30
• Public Version: 1
• Public Version Date: 2022-08-08
• Public Version Status: New
• Public Device Record Key: f059084c-5cc0-4808-9a95-2432fa8fd1c2

Device Description

Carmina, shower and commode chair with footrest and push bar

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
INN	Chair, Adjustable, Mechanical	Physical Medicine	890.3100	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34936	Shower seat, non-powered	A non-powered device designed to be sat upon by a patient (adult or child) while washing in a shower, or other washing facility (e.g., bath). The patient is typically disabled, infirm, or is undergoing medical treatment and requires to be seated while bathing/showering. The device may be in the form of a portable chair/stool or a fixed seat (e.g., wall-mounted), and may include armrests, side supports, or grab handles; it is typically made of water-resistant or waterproof materials (e.g., plastic and metal-coated materials). It may be used in a hospital, institution, or home.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05055982786980	GS1