MyCite Patch

GUDID 00857335005091

2 component patch RW2

Otsuka America Pharmaceutical Inc

Wearable multiple physiological parameter recorder Wearable multiple physiological parameter recorder Wearable multiple physiological parameter recorder Wearable multiple physiological parameter recorder Wearable multiple physiological parameter recorder Wearable multiple physiological parameter recorder Wearable multiple physiological parameter recorder Wearable multiple physiological parameter recorder Wearable multiple physiological parameter recorder Wearable multiple physiological parameter recorder Wearable multiple physiological parameter recorder Wearable multiple physiological parameter recorder Wearable multiple physiological parameter recorder Wearable multiple physiological parameter recorder Wearable multiple physiological parameter recorder Wearable multiple physiological parameter recorder Wearable multiple physiological parameter recorder, reusable Wearable multiple physiological parameter recorder, reusable Wearable multiple physiological parameter recorder, reusable Wearable multiple physiological parameter recorder, reusable Wearable multiple physiological parameter recorder, reusable Wearable multiple physiological parameter recorder, reusable Wearable multiple physiological parameter recorder, reusable Wearable multiple physiological parameter recorder, reusable

• Primary Device ID: 00857335005091
• NIH Device Record Key: cf349dc5-f295-4841-82f1-9c55363989a2
• Commercial Distribution Discontinuation: 2030-01-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MyCite Patch
• Version Model Number: RW2
• Company DUNS: 008314390
• Company Name: Otsuka America Pharmaceutical Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 609.535.9659
• Email: michael.fahmy@otsuka-us.com
• Phone: 609.535.9659
• Email: michael.fahmy@otsuka-us.com
• Phone: 609.535.9659
• Email: michael.fahmy@otsuka-us.com
• Phone: 609.535.9659
• Email: michael.fahmy@otsuka-us.com
• Phone: 609.535.9659
• Email: michael.fahmy@otsuka-us.com
• Phone: 609.535.9659
• Email: michael.fahmy@otsuka-us.com
• Phone: 609.535.9659
• Email: michael.fahmy@otsuka-us.com
• Phone: 609.535.9659
• Email: michael.fahmy@otsuka-us.com
• Phone: 609.535.9659
• Email: michael.fahmy@otsuka-us.com
• Phone: 609.535.9659
• Email: michael.fahmy@otsuka-us.com
• Phone: 609.535.9659
• Email: michael.fahmy@otsuka-us.com
• Phone: 609.535.9659
• Email: michael.fahmy@otsuka-us.com
• Phone: 609.535.9659
• Email: michael.fahmy@otsuka-us.com
• Phone: 609.535.9659
• Email: michael.fahmy@otsuka-us.com
• Phone: 609.535.9659
• Email: michael.fahmy@otsuka-us.com
• Phone: 609.535.9659
• Email: michael.fahmy@otsuka-us.com
• Phone: 609.535.9659
• Email: michael.fahmy@otsuka-us.com
• Phone: 609.535.9659
• Email: michael.fahmy@otsuka-us.com
• Phone: 609.535.9659
• Email: michael.fahmy@otsuka-us.com
• Phone: 609.535.9659
• Email: michael.fahmy@otsuka-us.com
• Phone: 609.535.9659
• Email: michael.fahmy@otsuka-us.com
• Phone: 609.535.9659
• Email: michael.fahmy@otsuka-us.com
• Phone: 609.535.9659
• Email: michael.fahmy@otsuka-us.com
• Phone: 609.535.9659
• Email: michael.fahmy@otsuka-us.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857335005091 [Primary]

FDA Product Code

• DXH: Transmitters And Receivers, Electrocardiograph, Telephone

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-22
• Device Publish Date: 2021-04-14

On-Brand Devices [MyCite Patch]

• 00857335005053: DW5 replacement patch
• 00857335005091: 2 component patch RW2