Comen

GUDID 06945429000009

Shenzhen Comen Medical Instruments Co., Ltd.

Transportable physiologic monitoring system

• Primary Device ID: 06945429000009
• NIH Device Record Key: 4e5a5163-12c8-4710-b7a2-d5f428fa5111
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Comen
• Version Model Number: C50
• Company DUNS: 529823362
• Company Name: Shenzhen Comen Medical Instruments Co., Ltd.
• 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: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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	06945429000009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112877

FDA Product Code

• DQA: Oximeter

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: 2019-10-11
• Device Publish Date: 2019-05-11

On-Brand Devices [Comen]

• 06945429085211: C60
• 06945429082548: C80
• 06945429055566: C30
• 06945429000009: C50
• 06945429010053: C80
• 06945429010046: C50