Detecto

Basic Information

• Brand Name: Detecto
• Primary DI: 00809161309201
• Version / Model: 6868KGEU-VER
• Company Name: CARDINAL SCALE MANUFACTURING COMPANY
• Labeler DUNS: 007153505
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-06-28
• Public Version: 1
• Public Version Date: 2019-07-08
• Public Version Status: New
• Public Device Record Key: c5d89f3f-02db-4e10-9c76-f29cc5041d4b

Device Description

OIML EC Class III 300 kg x 0.1 kg, Flip Seat w/Handrails,Veriified

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
FRI	Scale, Stand-On, Patient	General Hospital	880.2700	1

GMDN Terms

Code	Name	Definition	Implantable	Status
33255	Chair scale, electronic	A battery-powered device designed for weighing elderly and/or weak patients, patients with a disability, or patients undergoing a specific treatment (e.g., dialysis) who are unable to use a conventional floor scale. It is the form of a chair in which the patient sits and their weight subsequently measured and displayed. It is primarily used for routine patient weight checks, but is also used to continuously and accurately monitor body fluid gain and loss in dialysis patients. It is designed to provide accurate patient weight measurements regardless of patient position in the chair seat.	No	Active
38267	Stand-on floor scale, mechanical	A mechanical device designed to be placed on the floor and upon which a patient is intended to stand to measure and display total body weight. It is not designed to weigh a wheelchair-bound patient or bed/stretcher.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00809161309201	GS1