GUDID 06974757650112

GuangDong Youkey Medical Co., Ltd.

Hand-held ultrasound imaging system, body-surface

• Primary Device ID: 06974757650112
• NIH Device Record Key: 21ce7cbf-990c-46da-801b-61485c2dfdfc
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: P54
• Company DUNS: 714951617
• Company Name: GuangDong Youkey Medical 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06974757650112 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211746

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

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: 2023-11-17
• Device Publish Date: 2023-11-09

Devices Manufactured by GuangDong Youkey Medical Co., Ltd.

• 06974757650075 - NA: 2023-11-17
• 06974757650082 - NA: 2023-11-17
• 06974757650099 - NA: 2023-11-17
• 06974757650105 - NA: 2023-11-17
• 06974757650112 - NA: 2023-11-17
• 06974757650112 - NA: 2023-11-17
• 06974757650129 - NA: 2023-11-17
• 06974757650136 - NA: 2023-11-17