SMARTHEART

GUDID 10845717009376

JOYTECH HEALTHCARE CO.,LTD

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 10845717009376
• NIH Device Record Key: 17c4412a-0acc-4652-92b7-12d68e0d200d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SMARTHEART
• Version Model Number: 01-521
• Company DUNS: 544392778
• Company Name: JOYTECH HEALTHCARE CO.,LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00845717009379 [Primary]
GS1	10845717009376 [Package]; Contains: 00845717009379; Package: [48 Units]; In Commercial Distribution

FDA Product Code

• DXN: System, Measurement, Blood-Pressure, Non-Invasive

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-08
• Device Publish Date: 2019-02-13

Devices Manufactured by JOYTECH HEALTHCARE CO.,LTD

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• 16942284613297 - Rexall: 2025-08-13 8 Second Flex Tip Thermometer
• 16970392210398 - Rexall: 2025-08-13 Results in 60 Seconds Digital Thermometer
• 16970392212705 - SEJOY: 2025-08-11
• 26970392212955 - SEJOY: 2025-08-11
• 16970392213924 - SEJOY: 2025-08-11