Detecto

Basic Information

• Brand Name: Detecto
• Primary DI: 00809161311501
• Version / Model: APEX-SH-EU-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: 2022-09-16
• Public Version: 1
• Public Version Date: 2022-09-26
• Public Version Status: New
• Public Device Record Key: f3404f39-d207-45e6-9491-1523d8b43dbb

Device Description

OIML EC Class III, 280kg x 0.1kg, apex Series Scale, Non-Medical EU AC Adapter, Sonar Ht. Rod

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
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
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

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00809161311501	GS1