ANNE Chest Adhesive - Gentle Wear Shelf Box

Basic Information

• Brand Name: ANNE Chest Adhesive - Gentle Wear Shelf Box
• Primary DI: 00850064210309
• Version / Model: 900-00072
• Company Name: Sibel Health Inc.
• Labeler DUNS: 093772547
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-12-17
• Public Version: 1
• Public Version Date: 2025-12-25
• Public Version Status: New
• Public Device Record Key: 7faca6aa-462f-4768-84a1-8f987c6d117e

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	870.2910	2
BZQ	Monitor, Breathing Frequency	Anesthesiology	868.2375	2
FLL	Continuous Measurement Thermometer	General Hospital	880.2910	2
KMI	Monitor, Bed Patient	General Hospital	880.2400	1
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	870.2300	2
MWJ	Electrocardiograph, Ambulatory (Without Analysis)	Cardiovascular	870.2800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
12391	Wearable multiple physiological parameter recorder, reusable	An electrically-powered wearable device (e.g., wristband, watch, finger probe, head-worn sensor) designed to continuously or intermittently measure and record multiple physiological parameters [e.g., heart rate, respiration rate, electrocardiogram (ECG), haemoglobin oxygen saturation (Sp02), routine body movement] using one or more technologies [e.g., photoplethysmography (PPG), reflectance pulse oximetry, electrocardiography, accelerometry). The data is typically transferred to a smart device or central database for analysis, which might include evaluation of lifestyle factors (e.g., energy expenditure, activity level, sleep patterns). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850064210309	GS1

Premarket Submissions

Submission Number	Supplement Number
K240251	000