All-in-One Health Monitor

GUDID 06941900603523

Shenzhen Creative Industry Co., Ltd.

Multiple physiological parameter spot-check analysis system, clinical

• Primary Device ID: 06941900603523
• NIH Device Record Key: 8768ba04-6b83-4e12-aae6-46042f949895
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: All-in-One Health Monitor
• Version Model Number: PC-303
• Company DUNS: 547908801
• Company Name: Shenzhen Creative Industry 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06941900603523 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170047

FDA Product Code

• DSH: Recorder, Magnetic Tape, Medical

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: 2018-10-30
• Device Publish Date: 2018-09-29

Devices Manufactured by Shenzhen Creative Industry Co., Ltd.

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• 06941900601352 - Pulse Oximeter: 2025-01-06
• 06941900601369 - Pulse Oximeter: 2025-01-06
• 06941900601376 - Pulse Oximeter: 2025-01-06
• 06941900601383 - Pulse Oximeter: 2025-01-06