Detecto

Basic Information

• Brand Name: Detecto
• Primary DI: 00809161197907
• Version / Model: APEX-AC
• Company Name: CARDINAL SCALE MANUFACTURING COMPANY
• Labeler DUNS: 007153505
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-10-12
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 6427ac4a-6ea2-4b87-8060-3248cd360ca6

Device Description

apex Digital Clinical Scale, Includes Non-Medical-Grade AC Adapter, Mechanical Height Rod

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

GMDN Terms

Code	Name	Definition	Implantable	Status
37001	Patient-height measure	A device designed to measure the height of a patient. It can be, e.g., a wall-mounted graduated scale or a freestanding vertical graduated rod with an adjustable cross-piece that is placed on the top of the patient's head. It may provide analogue or digital readings.	No	Active
38211	Stand-on floor scale, electronic	An electrically-powered device designed to be placed on/integrated into 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	00809161197907	GS1