Detecto

Basic Information

• Brand Name: Detecto
• Primary DI: 00809161304206
• Version / Model: APEX-RI-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: 2019-10-15
• Public Version: 1
• Public Version Date: 2019-10-23
• Public Version Status: New
• Public Device Record Key: b9bc1475-3021-49ae-bea9-6d756c3fd470

Device Description

APEX Portable Scale, Remote Indicator, AC Adapter Included, 600 lb x 0.2 lb / 300 kg x 0.1 kg

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

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00809161304206	GS1