GUDID 06970379850275

Foshan MIC Medical Technology Co.,Ltd.

Mobile/portable oxygen concentrator

• Primary Device ID: 06970379850275
• NIH Device Record Key: 78ea35a5-3f78-46b1-97d1-6cc2d1affb24
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: CP501
• Company DUNS: 550677693
• Company Name: Foshan MIC Medical Technology 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: true
• 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	06970379850275 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202389

FDA Product Code

• CAW: Generator, Oxygen, Portable

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: 2022-06-10
• Device Publish Date: 2022-06-02

Devices Manufactured by Foshan MIC Medical Technology Co.,Ltd.

• 06970379850251 - NA: 2022-06-10
• 06970379850268 - NA: 2022-06-10
• 06970379850275 - NA: 2022-06-10
• 06970379850275 - NA: 2022-06-10
• 06970379850282 - NA: 2022-06-10
• 06970379850299 - NA: 2022-06-10