MyCite Patch

Basic Information

• Brand Name: MyCite Patch
• Primary DI: 00857335005053
• Version / Model: DW5
• Company Name: Otsuka America Pharmaceutical Inc
• Labeler DUNS: 008314390
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-01-08
• Public Version: 3
• Public Version Date: 2022-07-04
• Public Version Status: Update
• Public Device Record Key: 8f2d11ac-9309-4416-b1cf-2122ac9a4cd8
• Distribution End Date: 2021-09-30

Device Description

DW5 replacement patch

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
DXH	Transmitters And Receivers, Electrocardiograph, Telephone	Cardiovascular	870.2920	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	00857335005053	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 27 Degrees Celsius