MyCite Patch

GUDID 00857335005053

DW5 replacement patch

Otsuka America Pharmaceutical Inc

Wearable multiple physiological parameter recorder

• Primary Device ID: 00857335005053
• NIH Device Record Key: 8f2d11ac-9309-4416-b1cf-2122ac9a4cd8
• Commercial Distribution Discontinuation: 2030-01-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MyCite Patch
• Version Model Number: DW5
• Company DUNS: 008314390
• Company Name: Otsuka America Pharmaceutical Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: 410-353-8778
• Email: nancy.teague@otsuka-us.com
• Phone: 410-353-8778
• Email: nancy.teague@otsuka-us.com
• Phone: 410-353-8778
• Email: nancy.teague@otsuka-us.com
• Phone: 410-353-8778
• Email: nancy.teague@otsuka-us.com
• Phone: 410-353-8778
• Email: nancy.teague@otsuka-us.com
• Phone: 410-353-8778
• Email: nancy.teague@otsuka-us.com
• Phone: 410-353-8778
• Email: nancy.teague@otsuka-us.com
• Phone: 410-353-8778
• Email: nancy.teague@otsuka-us.com
• Phone: 410-353-8778
• Email: nancy.teague@otsuka-us.com
• Phone: 410-353-8778
• Email: nancy.teague@otsuka-us.com
• Phone: 410-353-8778
• Email: nancy.teague@otsuka-us.com
• Phone: 410-353-8778
• Email: nancy.teague@otsuka-us.com
• Phone: 410-353-8778
• Email: nancy.teague@otsuka-us.com
• Phone: 410-353-8778
• Email: nancy.teague@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
• 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	00857335005053 [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: 2021-01-18
• Device Publish Date: 2021-01-08

On-Brand Devices [MyCite Patch]

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