Patient Monitor

GUDID 06941900604285

Shenzhen Creative Industry Co., Ltd.

General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor

• Primary Device ID: 06941900604285
• NIH Device Record Key: c96e44b3-21fa-4375-bbec-ba8035af5a9f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Patient Monitor
• Version Model Number: PC-3000
• 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	06941900604285 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123711

FDA Product Code

• MWI: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

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: 2021-03-01
• Device Publish Date: 2021-02-19

Devices Manufactured by Shenzhen Creative Industry Co., Ltd.

• 06941900604407 - Pulse Oximeter: 2023-08-16
• 06941900604414 - Pulse Oximeter: 2023-08-11
• 06941900603011 - Pulse Oximeter: 2021-11-10
• 06941900603240 - Pulse Oximeter: 2021-11-10
• 06941900604001 - Handheld Pulse Oximeter: 2021-11-10
• 06941900604285 - Patient Monitor: 2021-03-01
• 06941900604285 - Patient Monitor: 2021-03-01
• 06941900600089 - Pulse Oximeter: 2019-10-22
• 06941900603066 - Easy ECG Monitor: 2018-11-16